FDAClass IIApril 1, 2015

Variable Angle Locking Peg recall

Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm…

Why was Variable Angle Locking Peg recalled?

Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots of Catalog Numbers: FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, FLP 126

Product
Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm…
Recalling firm
Flower Orthopedics Corporation
Quantity
901
Distribution
Distributed in the states of VA, TX, IL, OK, PA, CA, NY, KY, and FL.
Recall date
April 1, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls