Zimmer, Inc. 2022-10-12 Health serious FDA
Health · FDA · Recall #FDA-Z-0007-2023
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E),… Recall
Issued October 12, 2022 · Zimmer, Inc.
In October 2022, Zimmer, Inc. recalled the G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E),…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E),… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Zimmer, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Zimmer, Inc.
- Category
- Health
- Recall date
- October 12, 2022
- Units affected
- Not reported
- Sold at
- Domestic distribution US nationwide.
- Recall number
- FDA-Z-0007-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Zimmer, Inc. has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.