FDA (Devices) recall action 83820
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
The WHD/WHV impactors can rust over time due to an improper manufacturing process.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
TriMed Inc. is recalling 1,903 Peg Guide Extenders because the spring can rust due to the steel used. The product was distributed nationwide and to several foreign countries.
TriMed Inc. is recalling 99 nonsterile 1.7mm countersink instruments because the epoxy coating can pop off. The recall covers nationwide and specific foreign distribution.
TriMed Inc. is recalling 1,042 Locking Drill Guides because the epoxy coating on the instruments can pop off.
TriMed Inc. is recalling 467 Hex Drivers because the epoxy coating may pop off. The recall covers units distributed nationwide and to several foreign countries.
TriMed Inc. is recalling 561 Wrist Hook Dorsal and Volar Impactors because they can rust due to an improper manufacturing process.