FDAClass IIAugust 22, 2018

ARCOS Modular Revision Hip System recall

ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.

Why was ARCOS Modular Revision Hip System recalled?

Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.

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 621550 UDI (01)00880304474154(17)280206(10)621550

Product
ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
Recalling firm
Zimmer Biomet, Inc.
Quantity
12
Distribution
US distribution to CA, GA, IL, MO, NY, and VA.
Recall date
August 22, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls