Reported Jan 8, 2014 · Terminated
Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment…
Zimmer, 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, Inc. · 345 E Main St · Warsaw, IN · 46580-2746
Is this the product you have?
- Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is
- used in the treatment of the followingsevere pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661
- Lot codes and dates
Part 00-4349-036-11Lot 62393502
- Amount recalled
- 25
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
Why it was recalled
Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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