G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
Reported: October 12, 2022 Initiated: August 25, 2022 #Z-0007-2023
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.
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 56 US
- Distribution
- Domestic distribution US nationwide.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty. Recalled by Zimmer, Inc.. Units affected: 56 US.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 12, 2022. Severity: Moderate. Recall number: Z-0007-2023.
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