Zimmer G7 Acetabular System shells recalled due to packaging defect
Zimmer, Inc. is recalling certain G7 Acetabular System acetabular shells (52 MM and 60 MM) because the outer sterile package has corner walls thinner than specification, which could crack during transit and potentially lead to surgical complications or infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall involving a structural defect to a surgical implant package that could result in product damage, with potential for clinical harm including extended surgery or infection requiring intervention. However, no reported injuries or illnesses are stated in the source, so the score does not exceed 3 per the rubric.
Plain-English summary
Zimmer, Inc. is recalling 56 units of the G7 Acetabular System, Acetabular Shell (Item No. 010000663 in 52 MM size and Item No. 010000667 in 60 MM size) that were distributed nationwide in the United States. The outer sterile package cavity has a corner wall thickness below specification.
The thin corner wall could potentially crack during transit. FDA has classified this as a Class II recall. The potential risks from package damage during transport include non-clinically or clinically significant extension of surgery, or infection that could lead to surgical intervention.
Patients or healthcare providers who have received an implant from the affected lot numbers should contact Zimmer, Inc. for guidance. The affected lot numbers are 7286477, 7289929, 7296576, 7296633, and 7301697 for Item No. 010000663, and lot 7253325 for Item No. 010000667, both with expiration dates in June and July 2032.
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.
- Affected units
- 56
Distribution
Distributed nationwide across the United States.
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