Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico
This recall has been terminated (originally issued December 14, 2010).
- Company
- Stryker Endoscopy
- Recall Initiated
- August 20, 2009
- Posted
- December 14, 2010
- Terminated
- December 14, 2010
- Recall Number
- Z-0618-2011
- Quantity
- 447 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution: to one distributor in NJ.
Lot / Code Info
Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, serial numbers 09049AE2, 09050AE2, 09051AE2, 09052AE2, 09054AE4
Root Cause
Material/Component Contamination
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.