FDAClass IIDecember 27, 2017

ExploR Radial Head Replacement System. PN: 11-210061 recall

ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be…

Why was ExploR Radial Head Replacement System. PN: 11-210061 recalled?

Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular Radial HD lock screw was not included in the package for the stem.

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?

Part Lot UDI Number 11-210061 243610 and 202900; (01)00880304210448(17)260817(10)243610

Product
ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be…
Recalling firm
Zimmer Biomet, Inc.
Distribution
US, Canada, OUS.
Recall date
December 27, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls