Recall Z-0007-2023— Zimmer, Inc.

Name: FDA recall Z-0007-2023
Creator: U.S. Food and Drug Administration
Published: 2022-08-25

Class II · Ongoing

Class II FDA medical device recall by Zimmer, Inc., initiated 2022-08-25. It names one FDA 510(k) clearance: K121874. Product: G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty. Reason: The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-08-25
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K121874 — G7 ACETABULAR SYSTEMBiomet Manufacturing Corp·cleared 2012-11-23

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

G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty

Reason for recall

The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.

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