Recall Z-2782-2020— Flower Orthopedics Corporation

Name: FDA recall Z-2782-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-08

Class II · Terminated

Class II FDA medical device recall by Flower Orthopedics Corporation, initiated 2020-07-08, terminated 2020-10-08. It names one FDA 510(k) clearance: K133930. Product: Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.. Reason: The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium)..

Recalling firm: Flower Orthopedics Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-07-08
Terminated: 2020-10-08
Firm location: Horsham, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K133930 — FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SETFlower Orthopedics Corporation·cleared 2014-03-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.

Reason for recall

The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).

Data sourced from openFDA. This site is unofficial and independent of the FDA.