Zimmer Biomet Recalls ExploR Radial Head Replacement System Due to Missing Screw
Zimmer Biomet is recalling the ExploR Radial Head Replacement System because a complaint alleged the modular lock screw was missing from the package.
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 hazard is a missing component (lock screw) rather than a contamination or structural defect causing injury. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall involving a potential functional defect.
Plain-English summary
Zimmer Biomet, Inc. is conducting a Class II medical device recall for the ExploR Radial Head Replacement System (PN: 11-210061, LN: 243610 and 202900). The recall is being conducted due to a complaint alleging that the Modular Radial HD lock screw was not included in the package for the stem.
The affected product is an implantable stem with screw system. The distribution pattern for the recalled units includes the United States, Canada, and other overseas locations. The specific lot numbers involved are 243610 and 202900.
Healthcare providers and patients should check their inventory or medical records for this specific product and lot number. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed by Zimmer Biomet.
The recalled product
- Product
- ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
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 (1)
- (01)00880304210448(17)260817(10)243610
Distribution
Distribution scope not specified by the agency.
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