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Terminated

AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.

FDA Recall Z-2548-2018 · Posted None

Recalling FirmCayenne Medical Inc.
Recall StatusTerminated
Product CodeHTO
Date Initiated2010-04-28
Date Terminated2019-02-26
Product Quantity1,444 units total

Reason for Recall

A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.

Firm Action

Customers were contacted via email on approximately 10/10/2013 and were instructed to return any affected products on hand.

Root Cause

Component design/selection

Distribution Pattern

Worldwide distribution. US nationwide, Denmark, Finland, Malaysia, Netherlands, Poland, Switzerland, and Turkey.

Official Source

View FDA Recall →

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

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