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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 22, 2014
Date Posted August 16, 2014
Recall Status1 Terminated 3 on June 18, 2015
Recall Number Z-2251-2014
Recall Event ID 68819
510(K)Number K112885  
Product Classification Screw, fixation, bone - Product Code HWC
Product 4.0 mm Cancellous Screw, Partially Threaded
Sterile
Zimmer
Code Information Item Number 47-4840-010, 012, 014, 016, 018, 020, 022, 024, 026, 028, 030, 035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 095, 100-01
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
FDA Determined
Cause 2		 Package design/selection
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.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = ZIMMER, INC.
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