Zimmer Biomet Recalls A.L.P.S. Calcaneus Locking Plate Guide Inserts
Zimmer Biomet is recalling 22 A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts due to incorrect color anodization.
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 defect is a cosmetic labeling issue (incorrect color anodization) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 22 units of A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts (Item Number: 816209003, UDI: 00887868044670989403). The recall is classified as Class II by the U.S. Food and Drug Administration.
The reason for the recall is that the drill guides were manufactured with the incorrect color anodization. The affected units are identified by Package Lot 989430 and Lot Etched on Product P0284.
The products were distributed in the US states of Arizona, Missouri, Montana, New Jersey, New York, Ohio, Texas, and Washington, as well as in Chile and the Netherlands. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 22
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)
- Package Lot: 989430
- Lot Etched on Product: P0284
Distribution
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