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Terminated

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

FDA Recall Z-0034-2022 · Posted None

Recalling FirmFlower Orthopedics Corporation
Recall StatusTerminated
Product CodeHRS
Date Initiated2021-09-03
Date Terminated2022-07-28
Product Quantity77 kits

Reason for Recall

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

Firm Action

Coventus Flower Orthopedics issued letter dated 9/3/21 via email. Letter states reason fo recall, health risk and action to take: Check your inventory for the product listed below. Look into the see-through window in the box and determine if a CDG 200 is included. The CDG 200 resembles a pen and has a long, black handle and a silver tip. A photo of the CDG 200 is below: Next, please complete and return the attached Acknowledgement and Receipt Form by Friday, September 10, 2021. If you indicate on the form that you are in possession of an EWK 201 that is missing the CDG 200 component, Conventus Flower will ask that you return that affected kit. Conventus Flower will then send a replacement EWK 201 kit. Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or [email protected]

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123562FLOWER SMALL AND MEDIUM BONE IMPLANTSFlower Orthopedics Corporation · 2013-03-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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