Reported Oct 13, 2021 · Terminated

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

Flower Orthopedics Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Flower Orthopedics Corporation · 100 Witmer Rd Ste 280 · Horsham, PA · 19044-2647

Is this the product you have?

  • Flower E-Kit, Advanced-Bone
  • Fixation Fasterner-Fixation of RefEWK 201
Lot codes and dates
  • Lot Number2104321637
  • Unique Identifier00840118112079
Amount recalled
77 kits

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 28, 2022 · Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.