Biomet Recalls Low Profile Non-Locking Screws Due to Anodizing Error
Biomet is recalling 45 Low Profile Non-Locking Screws because they were anodized green instead of the required gold color.
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, but the hazard is a cosmetic anodizing error with no reported injuries or functional defects, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Biomet, Inc. is recalling 45 units of the Low Profile Non-Locking Screw (2.7mm x 22mm, Part Number 131227222, Lot RM105E). The recall was initiated after a company investigation determined that the screws were anodized green, whereas the manufacturing print required them to be anodized gold.
These orthopaedic devices are used by surgeons for bone fixation in fracture management and reconstructive surgeries. The affected units were distributed nationwide, including in California, Iowa, New York, Florida, Pennsylvania, Utah, North Carolina, South Carolina, Kentucky, Colorado, Massachusetts, Georgia, Washington, Texas, Oklahoma, and Illinois.
Healthcare providers and patients should contact Biomet for further instructions regarding the return or replacement of these specific devices.
The recalled product
- Product
- LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 45
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 (1)
- REF 131227222 LOT RM105E
Distribution
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