Biomet Recalls HipLOC CHS Plate/Lag Screw Introducer Due to Sizing Defect
Biomet is recalling 23 HipLOC CHS Plate/Lag Screw Introducers because some units are undersized and fail to accept the coupling screw.
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 source text describes a functional defect (undersized device) without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 23 units of the HipLOC CHS Plate/Lag Screw Introducer. The recall was initiated after a complaint indicated that the device was undersized and would not accept the introducer coupling screw. The issue appears to be that not all parts manufactured to the Rev A drawing were properly reworked.
The affected products are identified by Catalog Number 35-000263 and Lot Numbers 1807188, 1807189, 1943563, and 2577847. These units were distributed in the United States to the states of Missouri, Utah, Arizona, Illinois, Pennsylvania, Kentucky, Michigan, North Carolina, New Jersey, Minnesota, and Georgia, as well as internationally to The Netherlands.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Biomet is the recalling firm responsible for managing the recall.
The recalled product
- Product
- HipLOC CHS Plate/Lag Screw Introducer
- Manufacturer
- Biomet, Inc.
- Affected units
- 23
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 (5)
- Catalog Number: 35-000263
- and Lot Number Identification: 1807188
- 1807189
- 1943563
- and 2577847.
Distribution
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