Recall Z-0134-2019— Zimmer Biomet, Inc.

Name: FDA recall Z-0134-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-08

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-08-08, terminated 2020-07-30. It names one FDA 510(k) clearance: K100238. Product: Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures. Reason: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-08-08
Terminated: 2020-07-30
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 Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

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