Reported Jun 27, 2018 · Terminated
GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated…
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?
- GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
- Lot codes and dates
228829311230311260255105152590757210982070282057283729057650292980293094299420668040579470354970519980670820695640963100
- Amount recalled
- 449
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
Why it was recalled
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
This product could cause temporary or reversible health problems — stop using it.
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