FDAClass IIMarch 21, 2018

36mm Cocr Modular HD -6mm recall

36MM COCR MODULAR HD -6MM

Why was 36mm Cocr Modular HD -6mm recalled?

One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.

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?

11-363660 UDI Number: (01) 00880304210509 (17) 270507 (10) 236840 Product Number: 11-363660 Lot Number: 236840

Product
36MM COCR MODULAR HD -6MM
Recalling firm
Zimmer Biomet, Inc.
Quantity
23
Distribution
Outside USA
Recall date
March 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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