—#84865

Product

Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K071157
Affected lot / code info: Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, serial numbers 09049AE2, 09050AE2, 09051AE2, 09052AE2, 09054AE4

Why it was recalled

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 (FDA determination)

Material/Component Contamination

Action the firm took

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.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern: Nationwide Distribution: to one distributor in NJ.

Timeline

Recall initiated: 2009-08-20
Posted by FDA: 2010-12-14
Terminated: 2010-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84865. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.