FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico
- Recall number
- Z-0618-2011
- Recalling firm
- Stryker Endoscopy
- Product
- Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico
- Status
- Terminated
- Initiated
- 2009-08-20
- Posted
- 2010-12-14
- Terminated
- 2010-12-14
- Reason
- Potential breakage -- product may break while inserting it into the bone during surgery. This may prolong surgery, or, if undetected during surgery, result in retained fragments that may cause metal sensitization or immune response, or necessitate further intervention to retrieve the titanium fragments.
- Root cause
- Material/Component Contamination
- Action
- Stryker issued an Urgent Device Removal notification letter dated August 21, 2009 to consignees. Consignees were asked to acknowledge receipt and distribute the letter, track reponses, and destroy any returned material and document through weekly summary and records. Stryker can be contacted at 408 754-2000 about this recall.
- Quantity
- 447 units
- Distribution
- Nationwide Distribution: to one distributor in NJ.
- Lot, serial or model codes
- Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, serial numbers 09049AE2, 09050AE2, 09051AE2, 09052AE2, 09054AE4
- 510(k) numbers
- ["K071157"]
- PMA numbers
- not on file
- Product code
- HWC
- 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