Device is breaking while in use, potential for patients to require a revision surgery.
Flower Orthopedics
16 recalls • • Categories: Other Medical Devices, Implants & Prosthetics, Diagnostic Equipment
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
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Class I - Dangerous
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
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
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Class I - Dangerous
The product is being recalled due to incidence and reports of the product breaking during surgery.
Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.