Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 30 of 63
TriMed Inc.
Class II Terminated
Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
Reason: During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not...
Z-2262-2018 June 27, 2018 Santa Clarita, CA
TriMed Inc.
Class II Terminated
Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16
Reason: During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not...
Z-2264-2018 June 27, 2018 Santa Clarita, CA
TriMed Inc.
Class II Terminated
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
Reason: During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not...
Z-2263-2018 June 27, 2018 Santa Clarita, CA
TriMed Inc.
Class II Terminated
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
Reason: During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not...
Z-2265-2018 June 27, 2018 Santa Clarita, CA
MicroAire Surgical Instruments, LLC
Class II Terminated
MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed...
Reason: The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
Z-2107-2018 June 13, 2018 Charlottesville, VA
Zimmer Biomet, Inc.
Class II Terminated
Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee.
Reason: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Z-1737-2018 May 16, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.
Reason: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Z-1734-2018 May 16, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee.
Reason: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Z-1736-2018 May 16, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
Reason: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Z-1739-2018 May 16, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.
Reason: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Z-1738-2018 May 16, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
Reason: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Z-1735-2018 May 16, 2018 Warsaw, IN
Cook Inc.
Class II Terminated
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
Reason: The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
Z-1594-2018 May 9, 2018 Bloomington, IN
TriMed Inc.
Class II Terminated
Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; ...
Reason: Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto th...
Z-1373-2018 April 18, 2018 Santa Clarita, CA
Aesculap Implant Systems LLC
Class II Terminated
DS Titanium Ligation Clip Appliers, used in laparoscopic surgery
Reason: Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.
Z-1291-2018 April 11, 2018 Center Valley, PA
Zimmer Biomet, Inc.
Class II Terminated
TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruci...
Reason: Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Z-1072-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) r...
Reason: Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Z-1071-2018 March 21, 2018 Warsaw, IN
Steris Corporation
Class II Terminated
Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to en...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0757-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare provi...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0744-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare provide...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0745-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enc...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0749-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to e...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0761-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enc...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0748-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to ...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0768-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to e...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0763-2018 March 7, 2018 Mentor, OH
Steris Corporation
Class II Terminated
Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to e...
Reason: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the ext...
Z-0753-2018 March 7, 2018 Mentor, OH