Hip implant acetabular shells recalled due to packaging defect
Zimmer, Inc. is recalling G7 Acetabular System shells used in hip replacement surgery due to defective sterile packaging with corner walls below specification. The thin packaging could crack during shipping.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with a theoretical risk-of-harm and no reported illnesses or injuries to date. The potential for surgical complications and infection exists if the packaging is compromised during transit, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling G7 Acetabular System Acetabular Shells, specifically Item Numbers 010000663 (52 MM E) and 010000667 (60 MM G), used in hip arthroplasty procedures. The recall affects 56 units distributed nationwide in the United States.
The outer sterile package cavity has a corner wall thickness that is below the manufacturer's specification. This thin corner wall could potentially crack during transit, which may compromise the sterile condition of the implant.
Potential risks from the packaging defect include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention. The affected lot numbers are: Item 010000663 (Lots 7286477, 7289929, 7296576, 7296633, 7301697, expiring July 21, 2032) and Item 010000667 (Lot 7253325, expiring June 13, 2032).
Patients who have received this implant should contact their surgeon or healthcare provider for guidance on whether their implant is affected and what follow-up care may be needed.
The recalled product
- Product
- G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
- Manufacturer
- Zimmer, Inc.
- Hazard
- packaging-defect
- infection-risk
- surgical-complication
Distribution
Distributed nationwide across the United States.
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