Zimmer Biomet Recalls 2.5mm Orthopedic Pegs Due to Packaging Error
Zimmer Biomet is recalling 2.5mm orthopedic pegs because a larger 22mm peg was found in the package. The error affects 25 units distributed to Japan and the Netherlands.
What this means for you
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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a packaging error (wrong size device) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 25 units of the Peg Fully Threaded, Locking, 2.5mm x 10mm (Item Number 131212610). This orthopedic device is intended for the stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstructive surgeries of small bones in the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton, particularly in osteopenic bone.
The recall was initiated because a size 22mm threaded peg was found in the package of a 10mm unit. This packaging error poses a risk of using the incorrect device size during surgical procedures. The affected units are identified by Lot 969440 and UDI (01)00887868012310(17)280309(10)969440.
The affected products were distributed internationally to Japan and the Netherlands. Healthcare providers and facilities that have received these specific units should stop using them and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruct
- Manufacturer
- Zimmer Biomet, Inc.
- Category
- Medical Device — Orthopedic
- Affected units
- 25
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 (2)
- Lot 969440
- UDI (01)00887868012310(17)280309(10)969440
Distribution
Distribution scope not specified by the agency.
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