Recall Z-0165-06 ยท HWC Screw, Fixation, Bone
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
| Date | Nov 18, 2005 (initiated Aug 23, 2005) |
| Status | Terminated |
| 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/dist |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021351 | BIOSTEON CROSS PIN Biocomposites, Ltd., Oct 17, 2002 |