Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error
Smith & Nephew is recalling 58 R3 Acetabular 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, and the source text does not report any illnesses or injuries, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc. is recalling 58 units of the R3 Multi Hole HA Coated Hemispherical Stiktite Coated Shell. These are orthopedic implant components distributed worldwide in sizes ranging from 48mm to 64mm.
The recall was initiated because a manufacturing error resulted in out-of-specification R3 Acetabular Shells. The affected devices are identified by specific product reference numbers and lot numbers, including 71338733, 71338734, 71338735, 71338736, 71338737, 71338738, 71338740, and 71338741.
Healthcare providers and patients should contact Smith & Nephew for further instructions regarding the replacement or removal of these devices.
The recalled product
- Product
- smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant co
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 58
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 (14)
- 71338733
- Lot Numbers: 19DM28110
- 19DM28106
- 19DM28106A 71338734
- Lot Numbers: 19DM28114 71338735
- Lot Numbers: 19DM28116 71338736
- Lot Numbers: 19EM19673
- 19EM19683
- 19EM19678 71338737
- Lot Numbers: 18JM12872 71338738
- Lot Numbers: 18FM02387 71338740
- Lot Numbers: 18JM02713 71338741
- Lot Numbers: 19AM22770
- 19AM22770A
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 →Related recalls
Same manufacturer · Smith & Nephew, Inc.
See all →- HighTRIGEN proximal humeral nails are missing their distal holes
FDA (Devices) · 2026-06-24
- ModerateBone fixation screws recalled over a labeling error on one lot
FDA (Devices) · 2025-12-24
- ModerateSmith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
FDA (Devices) · 2025-05-28
- HighBIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
FDA (Devices) · 2024-12-11
- HighSmith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
FDA (Devices) · 2024-11-13
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-02
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12
- HighUSTAR II Knee System Hinge Box Trial Recall
FDA (Devices) · 2026-08-12