FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145 Intended for use in securing soft tissue to bone in certain procedures in specific areas.
- Recall number
- Z-1538-2008
- Recalling firm
- Stryker Endoscopy
- Product
- Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145 Intended for use in securing soft tissue to bone in certain procedures in specific areas.
- Status
- Terminated
- Initiated
- 2008-02-07
- Posted
- 2008-08-06
- Terminated
- 2010-12-21
- Reason
- Product package may crack and cause loss of sterility.
- Root cause
- Packaging
- Action
- 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.
- Quantity
- 53 units
- Distribution
- Product was distributed to 8 consignees in CA, OH, PA, CO, MA, and NJ.
- Lot, serial or model codes
- Lot Numbers 07299AE2
- 510(k) numbers
- ["K983557"]
- PMA numbers
- not on file
- Product code
- MBI
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28