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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Stryker Endoscopy
Lot Codes / Batch Numbers
04/05-PH134
Products Sold
04/05-PH134
Stryker Endoscopy is recalling Biosteon brand HA/PLLA Cross Pin, Model Number 234-500-350; Product is distributed by Stryker Endo due to The medical device is misbranded in that the package is labeled as Biosteon Interference Screw in fact contains Biosteon Cross Pin. This mislabeling . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
OR, VA
Page updated: Jan 10, 2026