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Terminated

StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer

FDA Recall Z-0948-03 · Posted 2003-06-21

Recall StatusTerminated
Product CodeHWC
Date Initiated2003-05-28
Date Terminated2003-09-12
Product Quantity159

Reason for Recall

Label may bear an incorrect part number [2227-02-02] and size [03.8MM].

Firm Action

A recall letter dated 5/28/03 was sent to the sole distributor, asking them to recall from their customers.

Root Cause

Other

Distribution Pattern

Indiana

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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