RegWardenFDA facility compliance records
Company

FLOWER ORTHOPEDICS CORPORATION

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

Recalls by year

FDA actions on record by year2015: 1 recalls; 2016: 1 recalls; 2020: 1 recalls; 2021: 4 recalls; 2023: 1 recalls12015120162017201820191202042021202212023202420252026
  • Recalls (8)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2023-08-29
    Device is breaking while in use, potential for patients to require a revision surgery.
  • Class IITerminated2021-11-02
    Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available
  • Class IITerminated2021-09-03
    Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
  • Class IITerminated2021-09-01
    Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
  • Class IITerminated2021-04-15
    Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages
  • Class IITerminated2020-07-08
    The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
  • Class IITerminated2016-12-22
    The product is being recalled due to incidence and reports of the product breaking during surgery.
  • Class IITerminated2015-02-16
    Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.

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. “FLOWER ORTHOPEDICS CORPORATION — 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-10044024-flower-orthopedics-corporation/

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