FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: Biosteon brand HA/PLLA Cross Pin, Model Number 234-500-350; Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138
- Recall number
- Z-0165-06
- Recalling firm
- Stryker Endoscopy
- Product
- Biosteon brand HA/PLLA Cross Pin, Model Number 234-500-350; Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138
- Status
- Terminated
- Initiated
- 2005-08-23
- Posted
- 2005-11-18
- Terminated
- 2005-11-21
- Reason
- The medical device is misbranded in that the package is labeled as Biosteon Interference Screw in fact contains Biosteon Cross Pin. This mislabeling could disrupt surgery preparation resulting in surgery delay.
- Root cause
- Other
- Action
- On 8/23/05, all consignees were notified via telephone, written letter and also via sales representative, informing them of the affected product and providing instructions on the recall.
- Quantity
- 495 units
- Distribution
- The product was distributed nationally to 8 consignees and internationally to 12 consignees via distributors and directly to physicians and/or medical facilities. Foreign countries include, Canada, Poland and Italy. It did not involve Defense Supply Center, VA or other Federal Government sales/distribution centers. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, physicians and medical facilities who received the recalled product.
- Lot, serial or model codes
- 04/05-PH134
- 510(k) numbers
- ["K021351"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- 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