Biomet Recalls G7 Acetabular Screws Due to Incorrect Diameter Labeling
Biomet is recalling G7 Acetabular Screws because the labels incorrectly list the diameter as 10.5mm instead of the actual 6.5mm.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error (incorrect diameter) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet, Inc. is recalling 532 units of G7 Acetabular Screws (6.5mm x 35mm, Part Number 010001000) in the United States. The recall was initiated after an investigation identified that the outer label, inner label, and patient label all incorrectly state the diameter size as 10.5mm. The actual screw diameter is 6.5mm, which correctly corresponds to the item number on the label.
The affected units are distributed worldwide, including in the USA, Europe, Italy, UK, Australia, and Japan. All product in the USA is under Biomet control. The specific lot numbers involved are 3070517, 3070528, 3077748, 3077750, 3077751, 3085183, 3105038, 3123395, 3123398, 3123399, 3123400, 3146439, 3165497, 3165498, 3165499, 3165500, and 3181736.
Healthcare providers and patients should verify the diameter of any implanted or pending G7 Acetabular Screws against the physical device rather than relying solely on the printed labels. Biomet is managing the recall of all units under its control in the United States.
The recalled product
- Product
- G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 532
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- Lot Numbers: 3070517
- 3070528
- 3077748
- 3077750
- 3077751
- 3085183
- 3105038
- 3123395
- 3123398
- 3123399
- 3123400
- 3146439
- 3165497
- 3165498
- 3165499
- 3165500
- 3181736
Distribution
Distributed nationwide across the United States.
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