FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by Smith & Nephew, Inc., Memphis, TN; ref: 111.100. Device is a surgical instrument.
- Recall number
- Z-2444-2008
- Recalling firm
- Zimmer Inc.
- Product
- Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by Smith & Nephew, Inc., Memphis, TN; ref: 111.100. Device is a surgical instrument.
- Status
- Terminated
- Initiated
- 2006-04-27
- Posted
- 2008-09-23
- Terminated
- 2009-03-11
- Reason
- The three-point array may break during use, resulting in surgical delay and an increased risk of infection.
- Root cause
- Device Design
- Action
- Consignee was notified by phone and email on or about 4/27/06. Contact Zimmer Inc. at 1-574-267-6131 for assistance.
- Quantity
- 239
- Distribution
- Nationwide
- Lot, serial or model codes
- Lots: PC040050, PC030403, PC040292, PC040293, PC050034, PC050129 and PC050034-1.
- 510(k) numbers
- ["K041369"]
- PMA numbers
- not on file
- Product code
- HAW
- 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