# FDA recall Z-0788-2024

> **Ossur H / F** · Class II · device recall initiated 2023-12-26.

## 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.

## Distribution

US Nationwide distribution including in the states of MA, SC, MD, TN, ND, VA, IL, NJ, FL, MI, NY, AL, TX, OK, IN, GA, CA, PA, NM, VT, NV, MS, HI, OH, WI, LA, IA, NE, MN, AR, OR, NC, NH, WV, CO, ID, AZ, MO, CT, WA, KY, UT, KS.

## Key facts

- **Recall number:** Z-0788-2024
- **Recalling firm:** Ossur H / F
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-26
- **Report date:** 2024-01-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Reykjavik, N/A, Iceland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0788-2024

## Citation

> AI Analytics. FDA recall Z-0788-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0788-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*