FDAClass IIOctober 23, 2019

OrthoPediatrics Adolescent attachment bolt used with recall

OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system…

Why was OrthoPediatrics Adolescent attachment bolt used with recalled?

Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures

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?

Lot/serial number: 192432-B 192279-B 189808-A 187375-A 177577-A 183280-A 175221-A 174784-A UDI: 00841132149836

Product
OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system…
Recalling firm
OrthoPediatrics Corp
Quantity
211 units
Distribution
Nationwide Foreign: Australia
Recall date
October 23, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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