PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
FDA Recall Z-1224-2018 · Posted None
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Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeJHW
Date Initiated2017-12-12
Date Terminated2019-04-09
Product Quantity3 units
Reason for Recall
A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.
Firm Action
On December 12, 2017 an URGENT MEDICAL DEVICE RECALL LETTER was issued to customers will the following guidance:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
Questions or concerns can be directed to 1-574-371-3071.
Root Cause
Under Investigation by firm
Distribution Pattern
Non-USA Customer
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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