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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer

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  Class 2 Device Recall Zimmer see related information
Date Initiated by Firm January 11, 2016
Date Posted March 12, 2016
Recall Status1 Terminated 3 on April 13, 2017
Recall Number Z-1136-2016
Recall Event ID 72900
510(K)Number K142281  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Product 38 consists of all product under product code: HSB and same usage:
Item no:
225303255 INTERLOCKING IM SCREW LG
225303555 INTERLOCKING IM SCREW LG
225303755 INTERLOCKING IM SCREW LG
225307055 INTERLOCKING IM SCREW LG
225302742 INTERLOCKING IM SCREW MED
225303242 INTERLOCKING IM SCREW MED
225307042 INTERLOCKING IM SCREW MED
225302737 INTERLOCKING IM SCREW SML
225303237 INTERLOCKING IM SCREW SML

Product Usage:
An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
Code Information lot no.: 61793328 62253390 61641813 62194666 61993625 62262085 62313056 62313056N 62021140 62312364 62312364N 61817404 61809837 61851878 61987145 62165485 62244841 62244854 61763549 61826386 61851889 61968098 62114111 62114112 62172486 61804389 61841502 61872521 61962448 61983689 62137121 62244852 61665045 61841504 62031683 62137150 62244853 61809838 62306323 62306323N 61830462 61809839 62189554 61804722 61830471 62165499 62165501 62189558 61809843 
Recalling Firm/
Manufacturer		 Zimmer Manufacturing B.V.
Turpeaux Industrial Park Rd 1 km 123.4
Mercedita PR 00715
For Additional Information Contact Consumer Relations Call Center
800-447-5633
Manufacturer Reason
for Recall		 As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
FDA Determined
Cause 2		 Packaging
Action Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.
Quantity in Commerce 4752
Distribution US Nationwide Distribution
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 = HSB and Original Applicant = ZIMMER, INC.
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