FDAClass IIAugust 24, 2016

Profemur(r) Modular Neck recall

PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain…

Why was Profemur(r) Modular Neck recalled?

Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).

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 number 1645222

Product
PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain…
Recalling firm
MicroPort Orthopedics Inc.
Quantity
14 units
Distribution
Belgium, Italy, Spain, and Poland
Recall date
August 24, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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