Agency classClass IIOur severity:High FDA (Devices)·Z-2333-2020·Announced 2020-06-17

Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

Smith & Nephew is recalling R3 Acetabular 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 involves an orthopedic implant with a manufacturing defect (out-of-specification) but does not report specific injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smith & Nephew, Inc. is recalling 6,468 units of the R3 Three Hole Hemispherical Stikitite Coated Shell, an orthopedic implant component. The recall was initiated because a manufacturing error resulted in out-of-specification devices.

The affected products are distributed worldwide and include various sizes ranging from 40mm to 60mm. Specific product reference numbers and lot numbers are listed in the official recall documentation.

Consumers and healthcare providers should check their inventory for the specific product reference numbers and lot numbers identified in the recall notice. If the product is found, it should be removed from use and returned to Smith & Nephew, Inc. according to the company's instructions.

The recalled product

Product: smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558…
Manufacturer: Smith & Nephew, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: manufacturing-defect
Affected units: 6,468

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)

71335540
Lot Numbers: 18JM08648
18JM08650
18MM12391 71335542
Lot Numbers: 18HM20695
18LM09821
19DM12897
19DM12898
19DM12899 71335544
Lot Numbers: 18LM02189
18LM02191
18LM02192
18MM08580
18MM08582 71335546
Lot Numbers: 19AM10686
19AM07909
18MM08601
18HM04443
18HM04455
18HM04461

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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