TriMed Inc.: The epoxy on Apex manufactured epoxy-coated instruments can pop off.; The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.; The WHD/WHV impactors can rust over time due to an improper manufacturing process.

Agency Publication Date: November 12, 2019

Affected Products

Product: TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

Lot number 91401455

Lot Numbers:

number

Product: TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

Lot numbers 3168, 3464, 3660, 3963, and 4216.

Lot Numbers:

numbers

Product: TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

Lot numbers 91500604 and 91600017

Lot Numbers:

numbers

Product: TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

Lot number 2858, 2861, and 3749

Lot Numbers:

number

Product: TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.

Lot numbers 049045, 049044, and 049044R1.

Lot Numbers:

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83820

Status: Active

Manufacturer: TriMed Inc.

Manufactured In: United States

Units Affected: 5 products (99 instruments; 1,042 drill guides; 467 hex drivers; 1,903 Peg Guide Extenders; 561 devices)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

Lot number 91401455

Lot Numbers:

number

Product: TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

Lot numbers 3168, 3464, 3660, 3963, and 4216.

Lot Numbers:

numbers

Product: TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

Lot numbers 91500604 and 91600017

Lot Numbers:

numbers

Product: TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

Lot number 2858, 2861, and 3749

Lot Numbers:

number

Product: TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.

Lot numbers 049045, 049044, and 049044R1.

Lot Numbers:

numbers