FDA recall Z-2548-2018

Product

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.

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2010-04-28

Report date

2018-08-01

Termination date

2019-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Scottsdale, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2548-2018