TriMed Recalls
19 recalls on record · September 28, 2016 to May 22, 2024 · Medical Devices
Recalls by year
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18
19
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24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 22, 2024Medical DevicesFDA
TriMed Inc. recalls TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65
Hazard: Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
May 22, 2024Medical DevicesFDA
TriMed Inc. recalls TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65
Hazard: Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
February 7, 2024Medical DevicesFDA
TriMed Inc. recalls Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-
Hazard: Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
February 15, 2023Medical DevicesFDA
TriMed Inc. recalls RipCord Syndesmosis Button, REF: STA001K
Hazard: 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.
November 20, 2019Medical DevicesFDA
TriMed Inc. recalls TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The
Hazard: 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 qualified.
November 20, 2019Medical DevicesFDA
TriMed Inc. recalls TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile,
Hazard: The WHD/WHV impactors can rust over time due to an improper manufacturing process.
November 20, 2019Medical DevicesFDA
TriMed Inc. recalls TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Hazard: The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.
November 20, 2019Medical DevicesFDA
TriMed Inc. recalls TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed In
Hazard: The epoxy on Apex manufactured epoxy-coated instruments can pop off.
November 20, 2019Medical DevicesFDA
TriMed Inc. recalls TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa
Hazard: The epoxy on Apex manufactured epoxy-coated instruments can pop off.
November 20, 2019Medical DevicesFDA
TriMed Inc. recalls TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita,
Hazard: The epoxy on Apex manufactured epoxy-coated instruments can pop off.
October 16, 2019Medical DevicesFDA
TriMed Inc. recalls TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varyi
Hazard: 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.
May 1, 2019Medical DevicesFDA
TriMed Inc. recalls TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System.
Hazard: The bone screw is shorter than the intended design specification.
August 29, 2018Medical DevicesFDA
TriMed Inc. recalls Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the r
Hazard: 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
June 27, 2018Medical DevicesFDA
TriMed Inc. recalls Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10
Hazard: 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. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
June 27, 2018Medical DevicesFDA
TriMed Inc. recalls Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d
Hazard: 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. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
June 27, 2018Medical DevicesFDA
TriMed Inc. recalls Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
Hazard: 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. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
June 27, 2018Medical DevicesFDA
TriMed Inc. recalls Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
Hazard: 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. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
April 18, 2018Medical DevicesFDA
TriMed Inc. recalls Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO;
Hazard: 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 sterilization tray or caddy.
September 28, 2016Medical DevicesFDA
Trimed Inc recalls TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in
Hazard: 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.