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Terminated

RSP Impaction Fixture

FDA Recall Z-1413-2017 · Posted None

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeHWA
Date Initiated2017-02-09
Date Terminated2017-10-20
Product Quantity626 units

Reason for Recall

During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.

Firm Action

There are two field safety notices, one for Consignees who have surgeons that use the impaction fixtures (Verson 1) and one for Consignees who had previously indicated their surgeons do NOT use the impaction fixtures (Verson 2). The two recall notification letters were sent out on 2/9/17.

Root Cause

Device Design

Distribution Pattern

US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany

Official Source

View FDA Recall →

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

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