TriMed Inc. — Federal Records

FDA Device Recall: TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx 2024-05-22

Class II — Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.

View Source

FDA Device Recall: TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx 2024-05-22

Class II — Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.

View Source

FDA Device Recall: Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VB 2024-02-07

Class II — Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.

View Source

FDA Device Recall: RipCord Syndesmosis Button, REF: STA001K 2023-02-15

Class II — Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.

View Source

FDA Recall: TriMed Inc. — Class II 20191120

The epoxy on Apex manufactured epoxy-coated instruments can pop off. | Product: TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed

View Source

FDA Device Recall: TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on 2019-11-20

Class II — The epoxy on Apex manufactured epoxy-coated instruments can pop off.

View Source

FDA Device Recall: TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the 2019-11-20

Class II — The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.

View Source

FDA Device Recall: TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm 2019-11-20

Class II — The epoxy on Apex manufactured epoxy-coated instruments can pop off.

View Source

FDA Device Recall: TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. 2019-11-20

Class II — The epoxy on Apex manufactured epoxy-coated instruments can pop off.

View Source

FDA Device Recall: TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, 2019-10-16

Class II — Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.

View Source

FDA Recall: TriMed Inc. — Class II 20180829

Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate | Product: Ulnar Osteotomy Compression Plate, Short Model: UOCP-S ...

View Source

FDA Device Recall: Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The U 2018-08-29

Class II — Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate

View Source

FDA Device Recall: Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x 2018-06-27

Class II — 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 be found...

View Source

FDA Device Recall: Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x1 2018-06-27

Class II — 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 be found...

View Source

FDA Device Recall: Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x 2018-06-27

Class II — 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 be found...

View Source

FDA Device Recall: Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x0 2018-06-27

Class II — 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 be found...

View Source

FDA Device Recall: TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with of 2016-09-28

Class II — TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted.

View Source