The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Art...
Reason: Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
Z-0123-2015October 29, 2014Warsaw, IN
Straumann USA, LLC
Class IITerminated
Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arche...
Reason: Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
Z-0117-2015October 29, 2014Andover, MA
Boston Scientific CRM Corp
Class IITerminated
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene ...
Reason: Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of ...
Z-0088-2015October 29, 2014Saint Paul, MN
Orthohelix Surgical Designs Inc
Class IITerminated
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired i...
Reason: Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
Z-0062-2015October 15, 2014Medina, OH
Stryker Spine
Class IITerminated
Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers i...
Reason: Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
Z-2626-2014September 17, 2014Allendale, NJ
Stryker Spine
Class IITerminated
Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System ...
Reason: Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
Z-2627-2014September 17, 2014Allendale, NJ
Mentor Texas, LP.
Class IITerminated
EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for singl...
Reason: The device labeling is stamped with 330cc and the device is actually 380cc device.
Z-2591-2014September 10, 2014Irving, TX
Customed, Inc
Class ITerminated
IMPLANTE DE ORTHOPEDIA - ( I) CAUTERY T IP POLI SHER LIF ( I) BAG SUTURE FLORAL LIF ( I) TUBE SUCTION CONNECT \14'' X 12' LIF ( I) BAG GLASSINE LIF (2) LITE GLOVE LIF (2) TABLE COVER 50" X 9...
Reason: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to th...
Z-2394-2014September 10, 2014Fajardo, PR
Customed, Inc
Class ITerminated
IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNEC...
Reason: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to th...
Z-2346-2014September 10, 2014Fajardo, PR
OrthoPediatrics Corp
Class IITerminated
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL re...
Reason: Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
Z-2560-2014September 10, 2014Warsaw, IN
St Jude Medical Cardiac Rhythm Management Division
Class IITerminated
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD130...
Reason: An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damage to the high voltage capacitors, which may result in extended charge time, occurri...
Z-2572-2014September 10, 2014Sylmar, CA
Customed, Inc
Class ITerminated
Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (2) TABLE COVER...
Reason: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to th...
Z-2492-2014September 10, 2014Fajardo, PR
Biomet Microfixation, LLC
Class IITerminated
Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reco...
Reason: Product mix occurred prior to final package and labeling process.
Z-2566-2014September 10, 2014Jacksonville, FL
Customed, Inc
Class ITerminated
ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP POLISHER UF (1) SKIN MARKER W/RULER (1) BAG SUTURE FLORAL (1) U - DRAPE 60" X 70" WITAPE SPLIT 6" X 2...
Reason: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to th...
Z-2509-2014September 10, 2014Fajardo, PR
Customed, Inc
Class ITerminated
ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" (1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8" X 7 Y:z" (1) TUBE SUCTION CONNECT. }4" X 12' (1...
Reason: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to th...
Z-2347-2014September 10, 2014Fajardo, PR
Zimmer, Inc.
Class IITerminated
Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
Reason: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, mul...
Reason: Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five forgings were not segr...
Z-2545-2014September 3, 2014Warsaw, IN
Zimmer, Inc.
Class IITerminated
Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST FNSTRD HIP 44HDX127ST FNSTRD HIP 45HDX140ST FNSTRD HIP...
Reason: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, mul...
Z-2551-2014September 3, 2014Warsaw, IN
Zimmer, Inc.
Class IITerminated
Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM ...
Reason: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, mul...
Reason: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, mul...
Z-2550-2014September 3, 2014Warsaw, IN
Zimmer, Inc.
Class IITerminated
Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ...
Reason: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, mul...
Z-2548-2014September 3, 2014Warsaw, IN
Zimmer, Inc.
Class IITerminated
Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA ENDO FEMORAL HEAD 45MM DIA ENDO FEMORAL HEAD 46MM DIA ...
Reason: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, mul...
Z-2547-2014September 3, 2014Warsaw, IN
Zimmer, Inc.
Class IITerminated
Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X110LG CANN BON...
Reason: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, mul...
Z-2549-2014September 3, 2014Warsaw, IN
AMO Puerto Rico Manufacturing, Inc.
Class IITerminated
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-2281-2014August 27, 2014Anasco, PR
AMO Puerto Rico Manufacturing, Inc.
Class IITerminated
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.