Z-0007-2023 Class II Ongoing
FDA device recall Z-0007-2023 was initiated by Zimmer, Inc. on Aug 25, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 56 US.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 12, 2022
- Initiation Date
- Aug 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56 US
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.
Distribution Pattern
Domestic distribution US nationwide.
Code Information
Item No. 010000663 UDI-DI: 00880304524224 Lots: 7286477 7289929 7296576 7296633 7301697 Exp. 21-Jul-32 Item No. 010000667 UDI-DI: 00880304524262 Lot: 7253325 Exp. 13-Jun-32
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0007-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026