—#162203

Product

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 product code: JHW — U.V. Method, Cpk Isoenzymes
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K122765
Affected lot / code info: Item# 42-5320-067-02 Lot # 63236047

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Non-USA Customer

Timeline

Recall initiated: 2017-12-12
Terminated: 2019-04-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162203. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.