Agency classClass IIOur severity:High FDA (Devices)·Z-2335-2020·Announced 2020-06-17

Smith & Nephew Recalls R3 Multi Hole Hemispherical Shells Due to Manufacturing Error

Smith & Nephew is recalling 1,766 R3 Multi Hole Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smith & Nephew, Inc. is recalling 1,766 units of the R3 Multi Hole Hemispherical Stiktite Coated Shell. The affected orthopedic implant components are available in sizes ranging from 48mm to 58mm. The recall covers devices distributed worldwide.

The recall was initiated because a manufacturing error resulted in out-of-specification R3 Acetabular Shells. The source text does not specify the exact nature of the specification failure or report any specific injuries or illnesses associated with the use of these devices.

Healthcare providers and patients who have received these specific orthopedic implants should contact Smith & Nephew or their medical provider for instructions on how to proceed. The recall includes specific product reference numbers and lot numbers, which are listed in the official FDA record.

The recalled product

Product: smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.
Manufacturer: Smith & Nephew, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: manufacturing-defect
Affected units: 1,766

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

71338663
Lot Numbers: 18EM10564
18EM23226
18EM23226A
18HM14882
18JM12818
18JM12819
18JM12819A
18KM09644
18LM19836
18MM07583
19BM10203
19CM19574
19CM19582
19DM28076
18KM25982
18MM07580
19DM15683
19EM19652
19EM19655

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 6 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Smith & Nephew, Inc.

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