The Recall Desk
HighFDA (Devices)·Z-0034-2022·Announced 2021-10-13

Flower E-Kit bone fixation kits recalled due to missing surgical component

Flower Orthopedics is recalling 77 Flower E-Kit bone fixation kits because they are missing a required CDG 200 Cannulated Countersink component. The incomplete kits could compromise orthopedic surgical procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device where a critical surgical component is missing from an orthopedic fixation kit. Per FDA classification, this is a Class II device. No illnesses or injuries have been reported in the source material, so the severity is 3 (High) per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Flower Orthopedics Corporation is recalling 77 Flower E-Kit (Advanced) bone fixation kits. Each kit is missing the CDG 200 Cannulated Countersink component, which is used with 3.0-4.5mm screws in orthopedic bone fixation procedures.

The missing component is necessary for completing bone fixation as designed. An incomplete surgical kit could prevent surgeons from performing the intended surgical fixation procedure and may compromise the safety of the operation.

The affected kits were distributed nationwide to healthcare facilities in Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, North Carolina, New York, Nevada, Ohio, West Virginia, and Texas. The affected lot number is 2104321637 (Unique Identifier: 00840118112079).

Healthcare facilities and physicians using these kits should immediately verify their inventory and discontinue use of affected units. Contact Flower Orthopedics Corporation for replacement components or replacement kits.

The recalled product

Product
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Manufacturer
Flower Orthopedics Corporation
Category
Medical Device — Orthopedic / Surgical
Hazard
  • missing-component
  • surgical-device-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 2104321637 Unique Identifier: 00840118112079

Distribution

Distributed nationwide across the United States.

Related recalls

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