Radio-Capitellum — Class II medical device recall Z-2428-2015
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2015-08-26. Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (ster
| Recall number | Z-2428-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2015-06-24 |
| Classified | 2015-08-20 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2016-04-29 |
| Quantity | 16,992 total |
| Reason classes | sterility, packaging |
| Lot numbers | 18565, 18832, 18834, 18836, 19069-S2, 19074-S2, 19077-S2, 19155S2, 22193201, 22193202, 22193203, 22193302, 22193303, 22193401, 22193402, 22193403, 22193501, 22193502, 22193503, 22258301, 22766801, 22766901, 22767001, 2295601, 22956301, 22956401, 22957101, 23853101, 23853201, 23853301, 23853901 |
| Model numbers | 410-0000, 410-0001, 410-0002, 410-0003 |
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.
Reason for recall
Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2428-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.