Zimmer Biomet

Certain sterile tourniquet extension hoses may have a breach in the sealing area of the sterile pouch, which could allow contamination. If used without detection, the hose could potentially cause a moderate localized infection at the surgical site.

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

Zimmer discovered that 12 units of the Persona Revision Trabecular Metal Femoral Distal Augment (Model 42-5572-066-10, Size 9/9+, 10mm thickness) contained an incorrect posterior augment component in the package instead of the correct distal augment. No patient injuries have been reported.

Zimmer identified a defect in the Off-Axis Alliance Glenoid Reamer Guide where plastic components can catch and break during the reaming procedure. Five complaints of this issue have been reported. The affected surgical instrument was distributed nationwide, with 13 units involved.

Zimmer, Inc. is recalling a surgical guide used during shoulder implant procedures. Five reports have identified that the plastic guide can catch and break during the reaming step of surgery, potentially affecting the procedure.

The plastic guide in Zimmer's Off-Axis Comprehensive Shoulder System reamer tool can catch during the reaming procedure, causing it to break. The FDA received five complaints about this issue. No injuries have been reported.

Zimmer has recalled a plastic reamer guide used during shoulder surgery due to reports of the guide catching and breaking during the reaming procedure. Five complaints have been received. No injuries have been reported.

Zimmer has recalled a plastic reamer guide used in shoulder surgery because the plastic can catch and break during the reaming procedure. Five complaints have been received describing this issue. No injuries have been reported.

The touchscreen on certain Zimmer A.T.S. 3200TS tourniquet systems may freeze or stop responding when the device is set to operate in certain non-English languages. This could delay surgery while staff locate an alternate device. The issue affects systems running software version 2.06 or earlier.

The screen on Zimmer A.T.S. 5000TS Tourniquet Systems may freeze or stop responding when used in certain non-English language settings. This can delay surgery while staff locate an alternate device. The issue affects systems running software version v2.04 or earlier.

Zimmer, Inc. is recalling certain Affixus 9 mm femoral nails (Model 815509300, Lot 66717550) used in hip and thigh bone fracture surgery. Some implants may have a thinner-than-expected diameter that could cause the nail to fracture over time, potentially requiring additional surgery.

Zimmer, Inc. is recalling a specific batch of Affixus Antegrade Femoral Nails (9 mm, 280 mm length, left Piriformis) used in thigh bone fracture repair. The affected implants may have a manufacturing defect that weakens the nail shaft and could cause it to break inside the leg. If this happens, patients may experience pain, improper bone healing, or need another surgery.

Zimmer has recalled certain Affixus Antegrade Femoral Nails (model 815609440) used in hip fracture surgery. Some implants may have a manufacturing defect that makes them thinner than intended, which could cause the implant to crack or break over time. This could lead to pain, improper healing, or the need for additional surgery.

Zimmer, Inc. is recalling specific lots of Affixus Antegrade Femoral Nails (9 mm, 420 mm length, left side) used in thighbone fracture surgery. Some implants may have a manufacturing defect that weakens the nail shaft, increasing the risk of the implant breaking inside the leg.

Zimmer Affixus Antegrade Femoral Nails (9 mm, 400 mm length, left side) may have a smaller-than-intended diameter along the shaft. This could cause the implant to weaken and break over time, leading to pain, improper bone healing, or the need for additional surgery.

Zimmer, Inc. is recalling specific Affixus Antegrade Femoral Nailing System implants (model 815609380, 9 mm, 380 mm length, left side) because they may have a manufacturing defect that makes the shaft undersized. This defect could cause the implant to break over time, potentially requiring additional surgery.

Zimmer, Inc. recalled certain Affixus Antegrade Femoral Nails (9 mm, 360 mm length, left side) because the shaft may be undersized and could fracture over time. A fractured implant could cause pain, improper bone healing, or require additional surgery.

Zimmer, Inc. recalled specific lots of Affixus Antegrade Femoral Nails (9 mm, 340 mm, Left) because the implant shaft may be undersized. This could cause the nail to break over time after surgical implantation, potentially leading to pain, improper bone healing, or the need for additional surgery.

Zimmer has recalled certain Affixus 9 mm femoral nails (320 mm length, left side) because the metal shaft may be undersized. This defect could cause the implant to crack over time, potentially leading to pain, improper bone healing, or the need for additional surgery.

Zimmer, Inc. is recalling certain Affixus 9 mm, 300 mm Left Trochanteric Femoral Nails (Model 815609300, Lot 66717600) because the implant shaft may be undersized, which could cause it to crack or break inside the body. If the nail fractures, patients may experience pain, improper bone healing, tissue damage, or need another surgery.

Zimmer, Inc. is recalling certain Affixus Antegrade Femoral Nails (model 815509440, 440 mm length) because the implant shaft may be undersized. This defect could cause the nail to break over time, potentially leading to pain, improper bone healing, or the need for additional surgery.

Zimmer, Inc. is recalling specific lots of the Affixus Antegrade Femoral Nailing System (a surgical implant used to stabilize thighbone fractures) because some units may have a manufacturing defect that could cause the implant to crack or break over time. If the implant breaks, it could lead to pain, improper bone healing, or the need for additional surgery.

Zimmer, Inc. is recalling specific lots of Affixus Antegrade Femoral Nails (model 815509400, 9 mm, 400 mm length) used in thigh bone surgery. Some implants may have a manufacturing defect that makes the shaft undersized, which could cause the nail to fracture over time.

Zimmer, Inc. is recalling certain Affixus Antegrade Femoral Nails (9 mm, 380 mm length, right-sided) because the implant shaft may be undersized. This manufacturing defect could cause the implant to break inside the body, potentially leading to pain, improper bone healing, or the need for additional surgery.

Zimmer, Inc. recalled certain Affixus 9 mm femoral nails (model 815509360, length 360 mm) because the shaft may be undersized and prone to breaking. If the implant fractures, it could cause pain, improper bone healing, tissue damage, or require additional surgery.

Zimmer, Inc. recalled 22 Affixus Antegrade Femoral Nails (9 mm, 340 mm length, right-sided) because the implants may have an undersized shaft diameter that could cause the nail to break inside the leg over time. If the implant fractures, it may cause pain, improper bone healing, tissue damage, or require additional surgery.

Zimmer, Inc. is recalling certain Affixus Antegrade Femoral Nails (9 mm, 320 mm length, right-sided) because the implant shaft may be undersized. This manufacturing defect could cause the nail to break over time, which may lead to pain, bone healing problems, or the need for additional surgery.

Zimmer Surgical Inc. is recalling certain Dermatome AN surgical devices (Model 88710100) because the thickness control bar may be misaligned. This could affect the device's ability to cut skin grafts to the correct thickness during surgery. No injuries have been reported.

Zimmer Surgical Inc. is recalling certain Zimmer Air Dermatome surgical devices because the thickness control bar may be misaligned. This could affect how the device operates during skin grafting procedures. No injuries have been reported so far.

Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.