Biomet Oxford Gap Gauge Recalled Due to Drafting Error
Biomet U.K., Ltd. is recalling 119 Oxford Gap Gauge instruments because a drafting error resulted in misleading dimensions on the product drawings.
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 source text describes a documentation/drafting error with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet U.K., Ltd. is recalling 119 units of the Oxford Gap Gauge SML 3/4mm. This medical instrument is used to check flexion and extension gaps when preparing the femur to accept a femoral component. The recall involves specific catalog and lot numbers distributed worldwide, including in the United States and several international countries.
The recall was initiated due to a drafting error that occurred during an unrelated design change. This error led to four misleading dimensions on the product drawing. Although the CAD model remained the same thickness, the problem dimensions were accidentally struck from an incorrect point, resulting in an increase of 1.0mm in the value of each dimension.
The affected units were distributed to the United States (including Indiana, South Dakota, and Texas) and the countries of Austria, China, Japan, Netherlands, Sweden, Turkey, and the UK. Healthcare providers and facilities should stop using the affected instruments and contact Biomet U.K., Ltd. for further instructions.
The recalled product
- Product
- Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.
- Manufacturer
- Biomet U.K., Ltd.
- Hazard
- Affected units
- 119
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 (6)
- Catalog Number: 32-422801 and Lot Number Identification: ZB111101
- ZBll1201
- ZB120101
- ZB120501
- ZB111102
- and ZB120201.
Distribution
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