Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total knee arthroplasty
FDA Recall Z-1159-2016 · Posted 2016-03-12
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Recalling FirmZimmer Manufacturing B.V.
Recall StatusTerminated
Product CodeJWH
Date Initiated2016-01-11
Date Terminated2017-04-13
Product Quantity39
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.
Firm 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 [email protected].
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.
Root Cause
Packaging
Distribution Pattern
US Nationwide Distribution
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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