I.T.S. GmbH foot and hallux osteotomy locking plates recalled for MRI safety concerns
I.T.S. GmbH has recalled certain foot locking plates and hallux osteotomy locking plates used in orthopedic surgery. New MRI safety testing found that these implants may heat up more than expected during MRI scans under certain conditions, which was not fully described in the original instructions.
From the FDA notice · Read the official notice ↗
What to do
- If you have received one of these implants, contact your surgeon or orthopedist for guidance before undergoing an MRI scan.
- Provide your surgeon with the specific article number and lot number of your implant (found on your surgical records or implant card).
- Do not postpone necessary medical imaging—discuss MRI safety concerns with your healthcare provider to determine the safest approach for your care.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.
- Sold in
- Nationwide
- Made for
- Adults (18 years to 100 years)
This recall covers 17 products — see all of them.
Details
- Units affected
- 15,517 units
- Illnesses reported
- None reported
- Manufactured in
- Autal 28, Lasnitzhohe, Austria
- Classification
- Class II
- Recall number
- Z-1605-2026
In the FDA's words
- Description
- FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09. Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). 1. Article Number (Lot Numbers): 37303-10 (18/151720, 18/268729, 679/032432, 679/072268, 679/102237, 679/102307), 37303-12 (18/570637, 679/032434, 679/072269, 679/102346, 679/112227), 37303-14 (18/751091, 26/F66913, 679/012510, 679/062288, 679/102359, 679/112410), 37303-16 (679/072263, 679/102245, 18/151841, 26/F66914, 18/331193, 18/543625, 679/012511, 679/042403, 679/102360), 37303-18 (18/151942, 18/210467, 18/231415, 18/341194, 18/572633, 18/771093, 679/012512, 679/022507, 679/042404, 679/102248, 679/112319), 37303-20 (18/152043, 18/211468, 18/351195, 18/573634, 18/701585, 18/781094, 679/022508, 679/042420, 679/112216, 679/112328), 37303-22 (18/171705, 18/212469, 18/361196, 18/574635, 18/791095, 679/022509, 679/042417, 679/112224, 679/112340), 37303-24 (18/575639, 18/741572, 26/F66915, 679/022510, 679/112226, 679/122313, 679/122333), 37303-26 (18/152346, 18/214471, 26/F66916, 679/012403, 679/112230, 679/122323), 37303-28 (26/F66917, 679/112231, 679/122328), 37303-30 (18/192716, 18/591743, 679/122334). 2. Article Number (Lot Numbers): 32271-10 (18/061949, 18/231167, 679/062351), 32271-12 (18/048927, 26/F66235, 679/042215, 679/062342, 679/062405, 679/062489, 679/072271), 32271-14 (18/049928, 18/231165, 26/F66140, 679/042210, 679/052340, 679/052518, 679/062471, 679/062490, 679/072267), 32271-16 (18/231164, 18/311125, 26/F66141, 679/042216, 679/052519, 679/062315, 679/062483, 679/072272, 679/072401), 32271-18 (18/062950, 26/F65556, 26/F66236, 679/032261, 679/062332, 679/072402), 32271-20 (18/063951, 26/F66237, 679/052326), 32271-22 (18/064952, 26/F65557, 679/032263, 679/062354), 32271-24 (18/065953, 26/F65558, 679/062333), 32271-26 (679/032265), 32271-28 (26/F65559, 679/062357, 679/052520), 32271-32 (26/F65561), 32271-34 (26/F65562). 3. Article Number (Lot Numbers): 37304-10 (18/635486, 26/F24799, 679/012419, 86/011176), 37304-12 (18/061352, 18/521172, 18/5211721, 18/576643, 18/630487, 679/012433, 679/092207, 679/122409), 37304-14 (18/081360, 18/531173, 18/5311731, 18/577644, 18/631488, 679/012434, 679/092208, 679/122410), 37304-16 (18/541174, 18/578645, 18/632489, 679/012444, 679/092201, 679/122411), 37304-18 (18/092020, 18/551175, 18/633490, 679/022403, 679/092202), 37304-20 (18/011320, 18/561176, 18/634491, 679/012287, 679/012420, 679/082217, 86/483331), 37304-22 (18/241273, 679/012288, 679/012421), 37304-24 (18/021321, 18/571177, 679/012289, 679/012445). 4. Article Number (Lot Numbers): 21413-6 (26/F52124). 5. Article Number (Lot Numbers): 21431-ME (679/102045). 6. Article Number (Lot Numbers): 21482 (679/092020), 21483 (26/F55902). 7. Article Number (Lot Numbers): 21421-5 (26/F65377, 679/092039). 8. Article Number (Lot Numbers): 37241-10 (18/012169, 18/610104, 18/701013), 37241-12 (18/231295, 18/767108), 37241-14 (18/511016, 18/537392, 26/F24807, 679/012280), 37241-16 (18/005340, 18/121106, 18/231387, 18/521017, 18/560517), 37241-18 (18/232328, 18/531018, 679/072408, 86/311848), 37241-20 (18/233388, 18/541020, 18/562519, 679/072419, 86/287847), 37241-22 (18/066109, 18/234389, 18/551021, 26/F24594, 26/F24811), 37241-24 (18/561022, 18/564521, 18/608110, 26/F24595), 37241-26 (18/611111, 18/711023, 26/F24596, 26/F24813), 37241-28 (18/612112, 18/721024, 18/811597, 26/F24597, 86/485508), 37241-30 (18/015172, 18/613113, 18/731019, 26/F24598). 9. Article Number (Lot Numbers): 21015-08 (00/0123-12, 00/0321-43, 00/0723-07), 21015-09 (00/0123-13). Distribution: US Nationwide distribution in the states of AL
- Hazard
- Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
17 products in this recall
I.T.S. bone plates and screws recalled for MRI heating risk
I.T.S. is recalling 17 orthopedic implant product lines, including bone plates and screw systems. Updated MRI safety testing found that these implants can heat up more during certain MRI conditions than the product instructions previously stated. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 2103…Z-1592-2026 · 220 units
- Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 2…Z-1593-2026 · 322 units
- Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7…Z-1594-2026 · 292 units
- FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.Z-1595-2026 · 4 units
- Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11…Z-1596-2026 · 101 units
- Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21…Z-1597-2026 · 70 units
- I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21…Z-1598-2026 · 510 units
- I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18,…Z-1599-2026 · 5,568 units
- Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike…Z-1600-2026 · 11 units
- I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Number…Z-1601-2026 · 869 units
- Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers:…Z-1602-2026 · 12,059 units
- I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plat…Z-1603-2026 · 176 units
- I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL…Z-1604-2026 · 120 units
- FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Lo… (this page)Z-1605-2026 · 15,517 units
- HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20,…Z-1606-2026 · 623 units
- HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 321…Z-1607-2026 · 1,307 units
- Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Pla…Z-1608-2026 · 46,637 units