Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, man
FDA device recall Z-0618-2011 · posted 2010-12-14 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 447 units
- Distribution
- Nationwide Distribution: to one distributor in NJ.
- Date initiated
- 2009-08-20
- Date posted
- 2010-12-14
- Date terminated
- 2010-12-14
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS (K071157) | Stryker Endoscopy | 2007-09-17 |