| Class 2 Device Recall Zimmer | |
Date Initiated by Firm | January 11, 2016 |
Date Posted | March 12, 2016 |
Recall Status1 |
Terminated 3 on April 13, 2017 |
Recall Number | Z-1116-2016 |
Recall Event ID |
72900 |
510(K)Number | K112885 |
Product Classification |
Screw, fixation, bone - Product Code HWC
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Product | Product 18 consists of all product under product code: HWC and same usage:
Item no:
47248001441 CANC SCR 4.0MM X 14MM FUL
47248001641 CANC SCR 4.0MM X 16MM FUL
47248001840 CANC SCR 4.0MM X 18MM
47248001841 CANC SCR 4.0MM X 18MM FUL
47248002041 CANC SCR 4.0MM X 20MM FUL
47248002441 CANC SCR 4.0MM X 24MM FUL
47248003641 CANC SCR 4.0MM X 36MM FUL
Product Usage:
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. |
Code Information |
lot no.: 62050736 62230456 62261576 61976745 62127763 62230457 62261627 62261659 61955473 |
Recalling Firm/ Manufacturer |
Zimmer Manufacturing B.V. Turpeaux Industrial Park Rd 1 km 123.4 Mercedita PR 00715
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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 | 83 |
Distribution | US Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = HWC
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