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Terminated

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

FDA Recall Z-0618-2011 · Posted 2010-12-14

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeHWC
Date Initiated2009-08-20
Date Terminated2010-12-14
Product Quantity447 units

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.

Firm 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.

Root Cause

Material/Component Contamination

Distribution Pattern

Nationwide Distribution: to one distributor in NJ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071157STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORSStryker Endoscopy · 2007-09-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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