Biosteon brand HA/PLLA Cross Pin, Model Number 234-500-350; Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138
FDA Recall Z-0165-06 · Posted 2005-11-18
Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeHWC
Date Initiated2005-08-23
Date Terminated2005-11-21
Product Quantity495 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.