FDAClass IIJune 17, 2020

Smith&nephew R3 NO Hole Hemispherical Stiktite Coated recall

smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848…

Why was Smith&nephew R3 NO Hole Hemispherical Stiktite Coated recalled?

A manufacturing error resulted in out of specification R3 Acetabular Shells

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

71331842, Lot Numbers: 18HM20691, 18LM09819, 18KM1572 71331848, Lot Numbers: 18HM01685, 19AM15804, 19AM15805, 19AM15809, 19AM15828, 19AM15829 71331850, Lot Numbers: 18LM00667, 18LM00668, 18LM00670, 18LM00671, 18LM00702, 18LM00668A, 18LM00671A 71331852, Lot Numbers: 19EM10292, 18KM20315, 18KM15739, 18KM20284, 18LM17941, 18LM02317, 18KM00744, 18KM00775, 18KM00779, 18KM00833, 18KM06667, 18KM06675, 18KM06676, 18KM06680, 18KM06681, 18KM06682, 18KM13594, 18KM13632, 18KM15736, 18KM15737, 18KM15738, 18KM20281, 18KM20289, 18KM20291, 18KM20292, 18KM24785, 18KM24792, 18KM24795, 18KM24805, 18LM02315, 18LM02337, 18LM17942, 18LM17946, 18KM20281A, 18LM07653, 18KM15736A, 18LM14077, 18KM24785A, 18KM20293A 71331854, Lot Numbers: 18JM13875, 18mm08723, 18JM13874, 19AM17866, 19AM17869, 18GM07436, 18GM07437, 18GM07438, 18GM07445, 18GM07469, 18GM07522, 18GM07533, 18KM03144, 18KM03147, 18KM03148, 18KM23654, 18KM23655, 18KM23662, 18MM08650, 18MM08663, 18MM08676, 18MM08678, 18MM08683, 18MM08695, 18MM08697, 18MM08724, 19AM17823, 19AM17833, 19AM17837, 19AM17845, 18MM08650A, 18MM08663A, 19AM17845A, 19AM17833A, 19AM17837A 71331856, Lot Numbers: 18JM15947, 18MM12475, 18JM15950, 18KM04251, 18HM19101, 18JM15940, 18KM04254, 18HM19123, 18KM15773, 18JM15949, 18JM15949A, 18LM18546, 18HM19116, 18HM19117, 18JM15941, 18KM04226, 18KM04250, 18KM04252, 18KM04253, 18KM13646, 18KM17025, 18KM17026, 18KM17029, 18KM17031, 18KM17032, 18LM18544, 18LM18550, 18MM12424, 18MM12426, 18MM12428, 18MM15587, 18MM15611, 18LM05390, 18KM17031A, 18LM18550A 71331858, Lot Numbers: 19AM03504, 19AM03511 71331860, Lot Numbers: 18JM10154, 18JM10154A

Product
smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848…
Recalling firm
Smith & Nephew, Inc.
Quantity
1267 devices
Distribution
Worldwide
Recall date
June 17, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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