Recall Z-0454-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0454-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-07

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-08-07, terminated 2019-03-29. It names one FDA 510(k) clearance: K100238. Product: Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM. Reason: 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..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-08-07
Terminated: 2019-03-29
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K100238 — HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MMDePuy Orthopaedics, Inc.·cleared 2010-05-11

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

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM

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.

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