Stryker Recalls Radio-Capitellum Implants Due to Packaging Integrity Concerns
Stryker Howmedica Osteonics Corp. is recalling specific Radio-Capitellum implants because transportation may have compromised the sterile barrier of the packaging.
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, and the hazard is a potential sterile barrier compromise due to transportation, which fits the criteria for a moderate risk without reported injuries.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling Radio-Capitellum, Capitellum, Left, Large, and related implant components. The recall involves 16,992 total units that were distributed worldwide. The specific products are indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
The recall is being conducted because the packaging integrity, specifically the sterile barrier of the packaging type KIT I, may potentially be compromised by transportation. This defect could affect the sterility of the medical devices.
Healthcare providers and patients should contact Stryker Howmedica Osteonics Corp. for further instructions regarding the return or replacement of these specific lots and part numbers.
The recalled product
- Product
- Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 16,992
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 (20)
- Part Number: 410-0000 (Radio Capitellum Large
- Left) - Lot #'s 18832
- 22193201
- 22193202
- 22193203
- 22258301
- 22957101
- 23853901
- 19069-S2
- 19077-S2 and 19155S2
- Part Number: 410-0001 (Radio Capitellum Small
- Left) - Lot #'s18833
- 18834
- 22193302
- 22193303
- 22766801
- 2295601 and 23853101
- Part Number: 410-0002 (Radio Capitellum Large
- Right) - Lot #'s18835
- 18836
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Stryker Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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