Reported Jul 24, 2019 · Terminated
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
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?
- Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
- Lot codes and dates
- Lots1411303¿
2510592549862037522606462630122647532111048211105221110502111051211101072111010621110117229101728810193231032298104633410198311291961120211101052111010819611201961120196112034611461961120196112019611201961120196112034611461081211108121110812111951228195122819512281951228195122831812033181203318120331812031411303
1411303172131217213121721312263135326313533461146MB337301714211721312ME50120ME501301641404MH50820164140416414042331407172131219611202291016346114623314072331407ML3570023314072631048ML565202331407233140723314072331407961509961509961509961509MO93600MO93610961509961509163151216315122261523226152322615232681520268152026815204438942681520443894443894476977476977501920501920530934538816
- Lots
- Amount recalled
- 1257
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of an adequate sterilization validation.
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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