Reported Dec 19, 2018 · Terminated
Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
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. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
- Lot codes and dates
- 068390
- Amount recalled
- 3 total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.
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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