—#124777

Product

Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement.

FDA product code: KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K070978
Affected lot / code info: Part numbers 00-5850-013-95

Why it was recalled

After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.

Root cause (FDA determination)

Device Design

Action the firm took

Depth of recall " Notifications were sent to customers, surgeons and risk managers, which use the affected product. Distributors were also informed of the notifications sent to surgeons and risk managers. The customers were identified by performing an invoice search and distribution history for the Polyethylene Inserts (00-5850-012-95 and 00-5850-013-95) since product launch. Recall Communication " All distributors were notified via electronic mail. Distributors that have received affected inventory were also notified via courier. Hospital risk managers and surgeons were also notified via courier. On 12/19/13, hospital risk managers and surgeons were provided with a notification identifying the issue and their responsibilities. These responsibilities include ensuring the affected personnel are aware of the contents of the notification. On 12/19/13, Distributors were sent a notification identifying the issue and to provide a copy of the notification sent to surgeons and risk managers. The distributors will also be instructed as needed to assist with identifying a comprehensive list of surgeons. " Communications outside of the United States will occur approximately two weeks after the United States communications. Effectiveness Checks Zimmer will conduct effectiveness checks in the following way: "Surgeons/Hospitals o100% of the FedEx notifications will be accounted for. oSecond and third notification attempts will be made. oFailed delivery attempts following the third attempt will result in the account being deemed as nonresponsive.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.

Timeline

Recall initiated: 2013-12-19
Posted by FDA: 2014-01-17
Terminated: 2015-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124777. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.