Reported Mar 7, 2018 · Terminated
Zimmer Segmental System, ZSS Distal Femur. Sizes as follows
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
Zimmer Segmental System, ZSS Distal Femur. Sizes as follows
4 of 4 products
| Model / number | Product as published |
|---|---|
00585001201 | Size B-LT ( ) |
00585001202 | Size B-RT ( ) |
00585001301 | Size C-LT ( ) |
00585001302 | Size C-RT ( ) Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration. |
- Amount recalled
- 3,350 units total
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
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