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Terminated

Stryker Peek Intraline Anchor, 6.5 mm with Needles, Model number 3910-400-025 Used for tissue fixation to bone in certain areas.

FDA Recall Z-1536-2008 · Posted 2008-08-06

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeHWC
Date Initiated2008-02-07
Date Terminated2010-12-21
Product Quantity125 units

Reason for Recall

Product package may crack and cause loss of sterility.

Firm Action

Stryker Endoscopy initiated the recall on 02/07/2008 by notifying its consignees via telephone, as well as sending out Urgent: Device Removal notices. Recipients of affected lots are to inspect their inventory for part/lot numbers and quarantine any affected product. Affected products are to be returned to Stryker Endoscopy and Customer Service should be contacted for replacement alternatives. Also, the "Acknowledgment of recipt" card needs to be signed and returned to Stryker Endoscopy.

Root Cause

Packaging

Distribution Pattern

Product was distributed to 8 consignees in CA, OH, PA, CO, MA, and 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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