I.T.S. Fibula Plate PROlock recalled for higher-than-expected MRI temperature increases
I.T.S. GmbH fibula plates used in orthopedic surgery have been recalled because new MRI safety testing found they heat up more than the instructions originally stated when exposed to certain MRI machine conditions. This could potentially cause tissue burns during an MRI scan.
From the FDA notice · Read the official notice ↗
What to do
- If you had orthopedic surgery with an I.T.S. fibula plate, inform your doctor or surgeon before any MRI procedure
- Check your surgical records or implant card for the article and lot numbers listed in the recall
- Contact your surgeon or hospital to confirm whether your plate is affected and discuss MRI safety with your healthcare provider
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.
- Sold in
- Nationwide
- Made for
- All ages
This recall covers 17 products — see all of them.
Details
- Units affected
- 869 units
- Illnesses reported
- None reported
- Manufactured in
- Autal 28, Lasnitzhohe, Austria
- Classification
- Class II
- Recall number
- Z-1601-2026
In the FDA's words
- Description
- I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16. 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): 21602-3 (643/072330, 643/092310), 21602-4 (643/072301, 643/072308), 21602-5 (643/022417, 643/0650, 643/072309), 21602-6 (643/042305, 643/072333), 21602-7 (643/072332, 643/082305), 21602-8 (43/0405, 643/012305), 21603-3 (643/072331, 643/082306), 21603-4 (643/102214, 643/102206, 643/072302, 643/022313, 643/032310), 21603-5 (643/072335, 643/122308), 21603-6 (643/022309, 643/072305, 643/072311, 643/122309), 21603-7 (643/072337, 643/082313), 21603-8 (643/072312, 643/122204). 2. Article Number (Lot Numbers): 21225-4 (768/20894, 26/F65041, 26/F66149, 679/092305, 679/022430, 26/F705141, 26/F72362, 26/F73634), 21225-6 (768/20895, 768/20039, 26/F65042, 26/F66150, 26/F66499, 679/092321, 26/F705161, 679/062459, 26/F70516, 26/F73635), 21225-8 (768/20896, 26/F65635, 26/F66500, 26/F70515), 21225-10 (26/F66497), 21225-12 (26/F66498, 679/012438), 21226-4 (26/F65043, 26/F66152, 26/F66501, 26/F70521, 26/F705211, 679/012412, 679/062306, 679/092306, 768/20897, 768/208978), 21226-6 (26/F35433, 26/F65044, 26/F66502, 26/F70522, 26/F705221, 679/062307, 679/092307, 768/20898), 21226-8 (26/F66503, 679/012413, 768/20045, 768/20899), 21226-10 (26/F66151), 21226-12 (26/F66148, 679/012411). 3. Article Number (Lot Numbers): 21601-5 (643/012302, 643/072323), 21601-6 (643/072326, 770/201904), 21601-7 (643/012303, 643/022308, 643/0647, 643/072315, 643/072327, 643/082303), 21601-8 (643/072328, 643/072329), 21601-10 (643/022312, 643/082301, 643/082302), 21601-12 (26/F70342), 21601-14 (26/F70343), 21601-16 (26/F70344). Distribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W. Affected quantity: 869 units
- 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… (this page)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…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