RegWardenFDA facility compliance records
Company

Extremity Medical, LLC

4 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2011: 2 recalls; 2012: 1 recalls; 2013: 1 recalls2’111’121’13’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2013-01-10
    The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.
  • Class IITerminated2012-03-22
    Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected).
  • Class IITerminated2011-04-25
    Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
  • Class IITerminated2011-04-13
    Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Extremity Medical, LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10027988-extremity-medical-llc/

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