FDAClass IIMarch 5, 2014

Reflection Interfit Shell recall

Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented…

Why was Reflection Interfit Shell recalled?

Inner spherical radius of the shell is undersized.

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?

Batch No. 13EM03053

Product
Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented…
Recalling firm
Smith & Nephew Inc
Quantity
10 units
Distribution
Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica.
Recall date
March 5, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls