Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 56 of 125
Integra Limited
Class II Terminated
Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment o...
Reason: Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Z-1089-2019 April 17, 2019 Plainsboro, NJ
Integra Limited
Class II Terminated
Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment ...
Reason: Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Z-1090-2019 April 17, 2019 Plainsboro, NJ
Zimmer Biomet, Inc.
Class II Terminated
Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant
Reason: Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
Z-1086-2019 April 10, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant
Reason: Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
Z-1087-2019 April 10, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 41...
Reason: Lack of an adequate sterilization validation
Z-1081-2019 April 10, 2019 Warsaw, IN
AAP Implantate Ag
Class II Terminated
aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support duri...
Reason: There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
Z-1019-2019 March 27, 2019 Berlin, N/A
ACell, Inc
Class II Terminated
Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists...
Reason: The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
Z-1032-2019 March 27, 2019 Columbia, MD
Cook Medical Incorporated
Class III Terminated
Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for t...
Reason: Updates to the Instructions for Use.
Z-1026-2019 March 27, 2019 Bloomington, IN
Cook Medical Incorporated
Class III Terminated
Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulm...
Reason: Updates to the Instructions for Use.
Z-1022-2019 March 27, 2019 Bloomington, IN
Cook Medical Incorporated
Class III Terminated
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention...
Reason: Updates to the Instructions for Use.
Z-1024-2019 March 27, 2019 Bloomington, IN
Cook Medical Incorporated
Class III Terminated
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pul...
Reason: Updates to the Instructions for Use.
Z-1021-2019 March 27, 2019 Bloomington, IN
Cook Medical Incorporated
Class III Terminated
Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product Usage: The Gunther Tulip Filter is intended for the prevention of recurrent ...
Reason: Updates to the Instructions for Use.
Z-1023-2019 March 27, 2019 Bloomington, IN
ACell, Inc
Class II Terminated
Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists...
Reason: The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
Z-1033-2019 March 27, 2019 Columbia, MD
Cook Medical Incorporated
Class III Terminated
Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention ...
Reason: Updates to the Instructions for Use.
Z-1025-2019 March 27, 2019 Bloomington, IN
RVO 2.0, INC
Class I Terminated
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
Reason: During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
Z-0865-2019 March 13, 2019 Aliso Viejo, CA
Zimmer Biomet, Inc.
Class II Terminated
Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
Reason: Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
Z-0937-2019 March 6, 2019 Warsaw, IN
Exactech, Inc.
Class II Terminated
Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where ana...
Reason: Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Hum...
Z-0958-2019 March 6, 2019 Gainesville, FL
Zimmer Biomet, Inc.
Class II Terminated
Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
Reason: Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
Z-0938-2019 March 6, 2019 Warsaw, IN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1
Reason: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a d...
Z-0807-2019 February 20, 2019 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers:...
Reason: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a d...
Z-0812-2019 February 20, 2019 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
Reason: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a d...
Z-0811-2019 February 20, 2019 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
Reason: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a d...
Z-0809-2019 February 20, 2019 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
Reason: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a d...
Z-0810-2019 February 20, 2019 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
Reason: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a d...
Z-0808-2019 February 20, 2019 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDR...
Reason: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a d...
Z-0806-2019 February 20, 2019 Mounds View, MN