Recall Z-2242-2016— Encore Medical, Lp

Name: FDA recall Z-2242-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-21

Class II · Terminated

Class II FDA medical device recall by Encore Medical, Lp, initiated 2016-06-21, terminated 2017-01-10. It names one FDA 510(k) clearance: K974294. Product: MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636. Reason: Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck..

Recalling firm: Encore Medical, Lp
Classification: Class II
Status: Terminated
Initiated: 2016-06-21
Terminated: 2017-01-10
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K974294 — ENCORE LINEAR POROUS COATED HIPEncore Orthopedics, Inc.·cleared 1998-01-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636

Reason for recall

Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.

Data sourced from openFDA. This site is unofficial and independent of the FDA.