Power Knee — Class II medical device recall Z-0788-2024
Ongoing recall by Ossur H / F, reported 2024-01-31, distributed nationwide. Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the d
| Recall number | Z-0788-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ossur H / F, Reykjavik, N/A, Iceland |
| Recall initiated | 2023-12-26 |
| Classified | 2024-01-25 |
| Reported by FDA | 2024-01-31 |
| Distributed | Nationwide (US) |
| Quantity | 544 batteries |
| UPC / GTIN / UDI-DI | 05690967648381, 05690967648404, 05690967648749 |
| Serial numbers | HF511036, HF511050, HF511065, HF511072, HF511081, HF511082, HF511084, HF511096, HF511098, HF511099, HF511104, HF511105, HF511119, HF511121, HF511122, HF511123, HF511124, HF511128, HF511130, HF511131, HF511132, HF511133, HF511136, HF511137, HF511138 and 475 more |
| Model numbers | PKA10001, PKA10002, PKA10003 |
Product
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Reason for recall
Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.
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-0788-2024. 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.