RegWardenFDA facility compliance records
Company

MedShape, Incorporated

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

Recalls by year

FDA actions on record by year2021: 1 recalls; 2025: 1 recalls201720182019202012021202220232024120252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-06-02
    Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.
  • Class IIOngoing2021-11-17
    The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure.

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. “MedShape, Incorporated — 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-10026693-medshape-incorporated/

Not open yet

Alerts for MedShape, Incorporated

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.