FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Literature for Implant Extraction Set - Implant Extraction Guide Module One & Two. Lists and describes the instruments which are in the Implant Extraction Set and the general application of these instruments for hardware removal.
- Recall number
- Z-1443-2010
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Literature for Implant Extraction Set - Implant Extraction Guide Module One & Two. Lists and describes the instruments which are in the Implant Extraction Set and the general application of these instruments for hardware removal.
- Status
- Terminated
- Initiated
- 2010-03-02
- Posted
- 2010-04-27
- Terminated
- 2012-08-06
- Reason
- Literature did not include the design change to a smaller cannulation diameter.
- Root cause
- Labeling Change Control
- Action
- An Urgent Correction - Operative Technique letter was sent to direct accounts, Hospital Risk Management, Chief of Orthopaedics and Surgeons that use the Gamma3 system. Notification letters were sent via Federal Express on March 2, 2010. The letter identified the product and described the issue. It also discussed the potential hazards and risk mitigation. Customers are to contact Customer Service at 1-866-OR-ASSIST or any of the other firm representatives listed in the letter.
- Quantity
- 790 unit
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- LIES-OT
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWB
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- 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