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.
What this means for you
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.
- Hazard
- 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.
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