Recall Z-0034-2022— Flower Orthopedics Corporation

Name: FDA recall Z-0034-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-03

Class II · Terminated

Class II FDA medical device recall by Flower Orthopedics Corporation, initiated 2021-09-03, terminated 2022-07-28. It names one FDA 510(k) clearance: K123562. Product: Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201. Reason: Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced).

Recalling firm: Flower Orthopedics Corporation
Classification: Class II
Status: Terminated
Initiated: 2021-09-03
Terminated: 2022-07-28
Firm location: Horsham, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K123562 — FLOWER SMALL AND MEDIUM BONE IMPLANTSFlower Orthopedics Corporation·cleared 2013-03-29

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

Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

Reason for recall

Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)

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