Stryker Endoscopy Stryker Wedge HS Suture Anchor II with Needles, 5.0 mm, Model number 3910-100-135. Intended for use in securing soft tissue to bone in certain procedures in specific areas. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker Wedge HS Suture Anchor II with Needles, 5.0 mm, Model number 3910-100-135. Intended for use in securing soft tissue to bone in certain procedures in specific areas.
Brand
Stryker Endoscopy
Lot Codes / Batch Numbers
Lot number 07298AE2, 07299AE2
Products Sold
Lot number 07298AE2, 07299AE2
Stryker Endoscopy is recalling Stryker Wedge HS Suture Anchor II with Needles, 5.0 mm, Model number 3910-100-135. Intended for use due to Product package may crack and cause loss of sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product package may crack and cause loss of sterility.
Recommended Action
Per FDA guidance
Stryker Endoscopy initiated the recall on 02/07/2008 by notifying its consignees via telephone, as well as sending out Urgent: Device Removal notices. Recipients of affected lots are to inspect their inventory for part/lot numbers and quarantine any affected product. Affected products are to be returned to Stryker Endoscopy and Customer Service should be contacted for replacement alternatives. Also, the "Acknowledgment of recipt" card needs to be signed and returned to Stryker Endoscopy.
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
CA, CO, IN, MA, NJ, OH, PA
Page updated: Jan 10, 2026