FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile, Stryker Howmedica Osteonics Corp, Mahwah, NJ 07430
- Recall number
- Z-1105-2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile, Stryker Howmedica Osteonics Corp, Mahwah, NJ 07430
- Status
- Terminated
- Initiated
- 2005-02-23
- Posted
- 2008-05-14
- Terminated
- 2008-05-30
- Reason
- Insertion/Removal Difficulties: The Baseplate Impactor/Extractor may not assemble/disassemble easily to the baseplate.
- Root cause
- Device Design
- Action
- Consignees were notified via an Important Market Withdrawal Letter sent 2/25/05. The letter instructed users to fax a Product Accountability Form to the recalling firm identifying any affected products and to return them to the firm. The letter informed users that the products will be reworked and returned at a later date. The letter also identified other products that could be used as replacements. For additional information, contact 201-831-5825 or 201-831-5110.
- Quantity
- 293 total units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Catalog Number 6541-4-805 Lot Code NYC08
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWA
- 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