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FASTPAK
Smith & Nephew, Inc. · Model 74013702 · UDI-DI 00885556747568
JWH
Prescription
10
510(k) clearances
158,735
Adverse events (262 deaths)
985
Recalls
318
Facilities
Description
JOURNEY II FASTPAK FEMORAL TRIAL, CAM MODULE, NOTCH TRIAL LEFT SIZE 2JOURNEY II FASTPAK FEMORAL TRIAL, CAM MODULE, NOTCH TRIAL LEFT SIZE 2
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-10-02 | CORIN MEDICAL, LTD. | Potential malfunction of the Modular Handles where the locking mechanism may fail. Any mating instruments already engaged to the handle will not be able to be disengaged, and the h |
| 2026-07-30 | Howmedica Osteonics Corp. | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o |
| 2026-05-20 | United Orthopedic Corp. | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| 2026-02-16 | Encore Medical, LP | Due to packaging discrepancy with incorrect product size mixed up. |
| 2026-02-16 | Encore Medical, LP | Due to packaging discrepancy with incorrect product size mixed up. |
| 2026-01-15 | Encore Medical, LP | Knee and Humeral socket implants contain incorrect labeling. |
| 2026-01-05 | Encore Medical, LP | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discr |
| 2025-07-31 | Waldemar Link GmbH & Co. KG (Mfg Site) | Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. |
| 2025-07-09 | Encore Medical, LP | Knee implants contain incorrect labeling (size and/or side incorrect) |
| 2025-07-09 | Encore Medical, LP | Knee implants contain incorrect labeling (size and/or side incorrect) |
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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.