Biomet Recalls A.L.P.S. Medium Bone Plate Forceps Due to Assembly Error
Biomet is recalling 223 units of A.L.P.S. Medium Bone Plate Forceps because they were assembled with incorrect grip arm tips, potentially preventing surgeons from clamping plates to bone.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the defect could prevent proper surgical clamping, but the source text does not report any injuries or illnesses, fitting the High severity criteria for theoretical risk without reported harm.
Plain-English summary
Biomet, Inc. is recalling 223 units of A.L.P.S. Medium Bone Plate Forceps, an orthopedic manual surgical instrument. The recall was initiated because the instruments were assembled with the incorrect grip arm tip.
The defect creates a potential risk that a surgeon will be unable to provisionally clamp the plate to the patient's bone during surgery. The affected products are identified by Part Number 816301006 and specific lot numbers including 099216, 093776, 093717, 093716, 088526, 081179, 072525, and 072524.
The recalled instruments were distributed domestically to Texas, New Jersey, North Carolina, Kentucky, Massachusetts, South Dakota, Missouri, Alabama, Indiana, Georgia, and Arkansas. International distribution included the Netherlands, Japan, and Costa Rica. Healthcare facilities should stop using these instruments and contact Biomet for instructions on return or replacement.
The recalled product
- Product
- A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
- Manufacturer
- Biomet, Inc.
- Affected units
- 223
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 (8)
- Part Number: 816301006 Lot Numbers: 099216
- 093776
- 093717
- 093716
- 088526
- 081179
- 072525
- 072524
Distribution
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