4.5 mm Malleolar Screw Sterile zimmer
FDA Recall Z-2250-2014 · Posted 2014-08-16
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Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2014-07-22
Date Terminated2015-06-18
Product Quantity47,682 units total
Reason for Recall
Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Firm Action
On 7/22/14, Zimmer sent recall notification to the consignees explaining the issue, identifying affected product, providing the health risks, and instructing the consignees what to do for the recall. Questions or concerns, please contact Zimmer at 1-877-946-2761.
Root Cause
Package design/selection
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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