Stanmore Implants Worldwide recalls
Stanmore Implants Worldwide appears in 8 official U.S. recall notices indexed by RecallRadar, most recently on 2017-09-13.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 8 |
|---|---|
| Published | 2016-05-18 to 2017-09-13 |
| By agency | FDA Device (8) |
| By classification | Class II (8) |
| By status | terminated (8) |
| Distribution named in notices | AL, CA, FL, GA, KS, MI, MS, NJ, OH, PA, SC, TX, US |
Recalls
- JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the di…
FDA Device · Class II · 2017-09-13 · Stanmore Implants Worldwide
Reason: Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in relation to the limb entry point of the device, together with the potential to select i… - Tibial Component Fixed Hinge Small Long
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide
Reason: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. - DF Coated Integral Shaft & Stem 15x30x38
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide
Reason: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. - Femoral Shaft L=120mm
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide
Reason: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. - Femoral Integral Shaft & Stem 15x27 HA Coated
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide
Reason: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. - Tibial Component Metal Cased Small Long
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide
Reason: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. - METS SMILES Total Knee Replacement
FDA Device · Class II · 2016-08-24 · Stanmore Implants Worldwide
Reason: The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to implantation. - Distal Femoral Replacement (patient specific, custom made orthopedic implant device)
FDA Device · Class II · 2016-05-18 · Stanmore Implants Worldwide
Reason: Incorrect component used to manufacture distal femoral replacement.