Agee-WristJack¿ Fracture Reduction System — Class II medical device recall Z-0136-2017
Terminated recall by Hand Biomechanics Lab Inc, reported 2016-10-26, distributed nationwide. A number of Agee WristJack¿ Fracture Reduction Systems have been manufactured with a molded beam slightly larg
| Recall number | Z-0136-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hand Biomechanics Lab Inc, Sacramento, CA, United States |
| Recall initiated | 2016-09-14 |
| Classified | 2016-10-18 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2016-11-15 |
| Distributed | Nationwide (US) |
| Quantity | 65 units |
| Reason classes | device malfunction |
| Lot numbers | HBL-115-165, HBL-116-014, HBL-116-040 |
| Serial numbers | 47460959, 47460980 |
| Model numbers | CFD-147 |
Product
Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.
Reason for recall
A number of Agee WristJack¿ Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. This may result in the surgeon experiencing difficulty fine-tuning the length (red) and radial/ulnar alignment (blue) adjustments on the device.
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-0136-2017. 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.