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.
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, 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
Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02