Reported Oct 24, 2012 · Terminated
CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by…
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?
- CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
- Lot codes and dates
- Lot 61947708
- Amount recalled
- 59 both units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. Zimmer received five complaints of this packaging issue.
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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