Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 104 of 125
AMO Puerto Rico Manufacturing, Inc.
Class II Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin...
Reason: Units may be labeled with the incorrect diopter power.
Z-2279-2014 August 27, 2014 Anasco, PR
AMO Puerto Rico Manufacturing, Inc.
Class II Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin...
Reason: Units may be labeled with the incorrect diopter power.
Z-2282-2014 August 27, 2014 Anasco, PR
AMO Puerto Rico Manufacturing, Inc.
Class II Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin...
Reason: Units may be labeled with the incorrect diopter power.
Z-2271-2014 August 27, 2014 Anasco, PR
Omnilife Science Inc.
Class II Terminated
Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
Reason: Staining on hip implant.
Z-2241-2014 August 27, 2014 East Taunton, MA
AMO Puerto Rico Manufacturing, Inc.
Class II Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin...
Reason: Units may be labeled with the incorrect diopter power.
Z-2276-2014 August 27, 2014 Anasco, PR
AMO Puerto Rico Manufacturing, Inc.
Class II Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin...
Reason: Units may be labeled with the incorrect diopter power.
Z-2277-2014 August 27, 2014 Anasco, PR
Medtronic Neuromodulation
Class II Terminated
Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimu...
Reason: Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.
Z-2259-2014 August 27, 2014 Minneapolis, MN
Synthes, Inc.
Class II Terminated
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Reason: A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testi...
Z-2265-2014 August 27, 2014 West Chester, PA
AMO Puerto Rico Manufacturing, Inc.
Class II Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin...
Reason: Units may be labeled with the incorrect diopter power.
Z-2275-2014 August 27, 2014 Anasco, PR
AMO Puerto Rico Manufacturing, Inc.
Class II Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin...
Reason: Units may be labeled with the incorrect diopter power.
Z-2273-2014 August 27, 2014 Anasco, PR
Ortho Development Corporation
Class II Terminated
Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
Reason: Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing ...
Z-2256-2014 August 27, 2014 Draper, UT
AMO Puerto Rico Manufacturing, Inc.
Class II Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin...
Reason: Units may be labeled with the incorrect diopter power.
Z-2286-2014 August 27, 2014 Anasco, PR
AMO Puerto Rico Manufacturing, Inc.
Class II Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin...
Reason: Units may be labeled with the incorrect diopter power.
Z-2283-2014 August 27, 2014 Anasco, PR
AMO Puerto Rico Manufacturing, Inc.
Class II Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin...
Reason: Units may be labeled with the incorrect diopter power.
Z-2287-2014 August 27, 2014 Anasco, PR
AMO Puerto Rico Manufacturing, Inc.
Class II Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin...
Reason: Units may be labeled with the incorrect diopter power.
Z-2280-2014 August 27, 2014 Anasco, PR
Ortho Development Corporation
Class II Terminated
Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component
Reason: Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing ...
Z-2254-2014 August 27, 2014 Draper, UT
Ortho Development Corporation
Class II Terminated
Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
Reason: Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing ...
Z-2253-2014 August 27, 2014 Draper, UT
Ortho Development Corporation
Class II Terminated
Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the f...
Reason: Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing ...
Z-2257-2014 August 27, 2014 Draper, UT
AMO Puerto Rico Manufacturing, Inc.
Class II Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin...
Reason: Units may be labeled with the incorrect diopter power.
Z-2285-2014 August 27, 2014 Anasco, PR
AMO Puerto Rico Manufacturing, Inc.
Class II Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin...
Reason: Units may be labeled with the incorrect diopter power.
Z-2274-2014 August 27, 2014 Anasco, PR
AMO Puerto Rico Manufacturing, Inc.
Class II Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin...
Reason: Units may be labeled with the incorrect diopter power.
Z-2278-2014 August 27, 2014 Anasco, PR
Ortho Development Corporation
Class II Terminated
PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
Reason: Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing ...
Z-2255-2014 August 27, 2014 Draper, UT
AMO Puerto Rico Manufacturing, Inc.
Class II Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin...
Reason: Units may be labeled with the incorrect diopter power.
Z-2272-2014 August 27, 2014 Anasco, PR
Integra LifeSciences Corp.
Class II Terminated
Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewPort System is intended to be used as a tempor...
Reason: Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility that components from the demonstration set may have been mixed with the NewPort MIS ...
Z-2182-2014 August 20, 2014 Plainsboro, NJ
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8803 The Codman Certas Programmable valve is an implantable device that provides constant intrave...
Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Z-2187-2014 August 20, 2014 Raynham, MA