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Terminated

Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001.

FDA Recall Z-0561-04 · Posted 2004-02-27

Recalling FirmPioneer Surgical Technology
Recall StatusTerminated
Product CodeHWC
Date Initiated2004-01-20
Date Terminated2004-05-20
Product Quantity318

Reason for Recall

Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.

Firm Action

Zimmer was notified of this recall via letter dated 1/20/04 requesting Zimmer to remove all of this lot from inventory and from point of use locations.

Root Cause

Other

Distribution Pattern

By Zimmer: Nationwide, Australia, Canada, Germany and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990804STAYFUSEPioneer Surgical Technology · 1999-04-29

Official Source

View FDA Recall →

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

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