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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-1112-2016
Recall Event ID 72900
510(K)Number K032367  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Product 14 consists of all product under product code HSB
, and same usage:
Item no:
225600230 ASIA ONE-PIECE LAG SCREW
225600232 ASIA ONE-PIECE LAG SCREW
225600235 ASIA ONE-PIECE LAG SCREW
225600237 ASIA ONE-PIECE LAG SCREW
225600240 ASIA ONE-PIECE LAG SCREW
225600242 ASIA ONE-PIECE LAG SCREW
225600245 ASIA ONE-PIECE LAG SCREW
225600227 ASIA ONE-PIECE LAG SCREW 70MM

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.: 61902234 61930449 62238240 61781914 61818112 61873640 61873641 61921821 61930453 62142331 62171289 61656184 61656185 61663560 61818114 61818116 61818118 61873642 61930459 61969224 61969225 62118686 62238244 62250669 62279154 62279156 61640868 61781919 61781920 61866144 61866145 61969228 62122251 62142308 62171295 62255624 62279159 61663622 61781922 61781927 61831643 61862302 61930474 62142311 62232636 62238251 62283223 62283223N 61663623 61781928 61866147 62092290 62155425 62031720 
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 0
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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