4.5 mm Malleolar Screw Sterile zimmer
Reported: August 27, 2014 Initiated: July 22, 2014 #Z-2250-2014
Product Description
4.5 mm Malleolar Screw Sterile zimmer
Reason for Recall
Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 47,682 units total
- Distribution
- National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
4.5 mm Malleolar Screw Sterile zimmer. Recalled by Zimmer, Inc.. Units affected: 47,682 units total.
Why was this product recalled? ▼
Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 27, 2014. Severity: Moderate. Recall number: Z-2250-2014.
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