Medical DeviceMay 22, 2024
TriMed recall — FDA Z-1792-2024
Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
Class IIFDA: OngoingTriMed Inc.
Recall history in this database
Classification mix: Class II: 19.
Medical DeviceMay 22, 2024
TriMed recall — FDA Z-1791-2024
Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
Class IIFDA: OngoingTriMed Inc.
Medical DeviceFeb 7, 2024
TriMed Volar Bearing Plate recall — FDA Z-0932-2024
Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
Class IIFDA: OngoingTriMed Inc.
Medical DeviceFeb 15, 2023
TriMed RipCord Syndesmosis Button, REF: STA001K recall — FDA Z-1101-2023
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.
Class IIFDA: OngoingTriMed Inc.
Medical DeviceNov 20, 2019
TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx recall — FDA Z-0355-2020
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Class IIFDA: OngoingTriMed Inc.
Medical DeviceNov 20, 2019
TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx recall — FDA Z-0358-2020
The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.
Class IIFDA: OngoingTriMed Inc.
Medical DeviceNov 20, 2019
TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx recall — FDA Z-0356-2020
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Class IIFDA: OngoingTriMed Inc.
Medical DeviceNov 20, 2019
TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx recall — FDA Z-0357-2020
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Class IIFDA: OngoingTriMed Inc.
Medical DeviceNov 20, 2019
TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) recall — FDA Z-0366-2020
The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully…
Class IIFDA: TerminatedTriMed Inc.
Medical DeviceNov 20, 2019
TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD recall — FDA Z-0359-2020
The WHD/WHV impactors can rust over time due to an improper manufacturing process.
Class IIFDA: OngoingTriMed Inc.
Medical DeviceOct 16, 2019
TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or recall — FDA Z-0118-2020
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.
Class IIFDA: TerminatedTriMed Inc.
Medical DeviceMay 1, 2019
TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the recall — FDA Z-1214-2019
The bone screw is shorter than the intended design specification.
Class IIFDA: TerminatedTriMed Inc.
Medical DeviceAug 29, 2018
TriMed Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is recall — FDA Z-2877-2018
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
Class IIFDA: TerminatedTriMed Inc.
Medical DeviceJun 27, 2018
TriMed Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15 recall — FDA Z-2264-2018
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.…
Class IIFDA: TerminatedTriMed Inc.
Medical DeviceJun 27, 2018
TriMed Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14 recall — FDA Z-2263-2018
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.…
Class IIFDA: TerminatedTriMed Inc.
Medical DeviceJun 27, 2018
TriMed Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17 recall — FDA Z-2262-2018
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.…
Class IIFDA: TerminatedTriMed Inc.
Medical DeviceJun 27, 2018
TriMed Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08 recall — FDA Z-2265-2018
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.…
Class IIFDA: TerminatedTriMed Inc.
Medical DeviceApr 18, 2018
TriMed Hex Driver Part Number HXDRIVER-2.0 AO recall — FDA Z-1373-2018
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 the…
Class IIFDA: TerminatedTriMed Inc.
Medical DeviceSep 28, 2016
TriMed Semi-Tubular Plate, 10-Hole, Model No recall — FDA Z-2849-2016
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.
Class IIFDA: TerminatedTrimed Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Trimed Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.