Reported Oct 7, 2015 · Terminated
Zimmer Guide Wires for orthopedic procedures.
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. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- Zimmer Guide Wires for orthopedic procedures.
- Lot codes and dates
- 00-2228-024-00 2.4MM Diameter Bullet Tip Guide Wire; 00-2255-025-00 Humeral Smooth Guide Wire 2.4mm 70cm Length; 00-2255-026-00 Humeral Bullet Tip Guide Wire 2.4mm Diameter 70cm Length; 47-2237-033-00 Smooth Guide Wire 2.4mm Diameter 100cm Length; 47-2237-037-00 3.0MM Diameter Smooth Guide Wire 100cm Length; 47-2237-038-00 Bullet Tip Guide Wire 3.0mm Diameter 100cm Length; 47-2255-008-00 Ball Tip Guide Wire 2.4mm Diameter 70cm Length; 47-2255-008-01 Ball Tip Guide Wire 3.0mm Diameter 100cm Length All non-expired, distributed lots with a 10 year expiration date on the label.
- Amount recalled
- 112,568 units
Where it was sold
- Nationwide
- PR
Why it was recalled
Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires.
This product could cause temporary or reversible health problems — stop using it.
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