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External Remote Controller
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. · Model P003 · UDI-DI 00856719002220
HSB
Prescription
10
510(k) clearances
37,835
Adverse events (115 deaths)
690
Recalls
301
Facilities
Description
External remote controller - for use with the FREEDOM residual limb lengthening system
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-16 | Smith & Nephew, Inc. | Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.