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Terminated

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM

FDA Recall Z-0460-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2017-08-07
Date Terminated2019-03-29
Product Quantity638 units

Reason for Recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Firm Action

Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed.

Root Cause

Process change control

Distribution Pattern

US nationwide distribution. Also Portugal and the Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100238HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MMDePuy Orthopaedics, Inc. · 2010-05-11

Official Source

View FDA Recall →

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

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