FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement.
- Recall number
- Z-0784-2014
- Recalling firm
- Zimmer, Inc.
- Product
- Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement.
- Status
- Terminated
- Initiated
- 2013-12-19
- Posted
- 2014-01-17
- Terminated
- 2015-02-24
- Reason
- 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
- Device Design
- Action
- 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.
- Quantity
- 5305 distribution events
- Distribution
- Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.
- Lot, serial or model codes
- Part numbers 00-5850-013-95
- 510(k) numbers
- ["K070978"]
- PMA numbers
- not on file
- Product code
- KRO
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28