Biosteon brand HA/PLLA Cross Pin, Model Number 234-500-350; Product is distributed by Stryker Endoscopy, 5900 Optical Co
FDA device recall Z-0165-06 · posted 2005-11-18 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 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, Po
- Date initiated
- 2005-08-23
- Date posted
- 2005-11-18
- Date terminated
- 2005-11-21
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOSTEON CROSS PIN (K021351) | Biocomposites, Ltd. | 2002-10-17 |