Smith & Nephew R3 Acetabular Shells Recalled for Manufacturing Error
Smith & Nephew is recalling R3 No 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 involves a medical device with a manufacturing error resulting in out-of-specification components. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc. is recalling the R3 No Hole Hemispherical Stiktite Coated Shell, an orthopedic implant component. The recall involves 1,267 devices distributed worldwide in sizes ranging from 42mm to 60mm.
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 deviation or report any associated illnesses or injuries.
Healthcare providers and patients who have received these specific devices should contact Smith & Nephew for further instructions on how to proceed.
The recalled product
- Product
- smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 1,267
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)
- 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
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 error
See all →- HighStraumann angled custom abutments made from wrong bar material
FDA (Devices) · 2026-04-01
- HighStraumann custom abutments made from wrong bar material after mix-up
FDA (Devices) · 2026-04-01
- HighMedtronic tissue stabilizer recalled after tubing was assembled in reverse
FDA (Devices) · 2026-03-04
- HighDASH COVID and flu tests may give a false negative result
FDA (Devices) · 2025-08-13
- HighRAPIDPoint 500 wash waste cartridge lot biases seven blood analytes
FDA (Devices) · 2025-08-06