Biomet Recalls Straight Acetabular Inserter Handles Due to Latch Interference
Biomet, Inc. is recalling 58 non-sterile Straight Acetabular Inserter Handles because they may lock onto the cup during surgery, potentially causing delays.
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. The hazard involves a potential surgical delay rather than direct physical injury or death, fitting the criteria for moderate severity where the risk is operational rather than immediate physical harm.
Plain-English summary
Biomet, Inc. is recalling 58 units of the REF S313152 Straight Acetabular Inserter Handle Ringloc, a non-sterile orthopedic manual surgical instrument. The recall covers specific catalog number 5313152 and lot numbers 153880, 153930, 415500, and 648010. These products were distributed internationally to Canada, Japan, and Chile, with no distribution in the United States.
The recall was initiated because the inserter handles may have been manufactured at the higher end of the tolerance, causing interference with the Ringloc cup. This defect may cause the inserter handle to lock onto the cup during impaction. If alternative inserters are not available, this issue could result in a surgical delay of greater than 30 minutes.
Healthcare facilities and distributors in Canada, Japan, and Chile should stop using the affected devices and contact Biomet, Inc. for instructions on return or replacement. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
- Manufacturer
- Biomet, Inc.
- Affected units
- 58
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 (4)
- Catalog Number 5313152 Lot 153880
- 153930
- 415500
- 648010
Distribution
Distribution scope not specified by the agency.
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