Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error
Smith & Nephew is recalling 1,450 R3 Zero Hole HA Coated 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, and the hazard involves a risk-of-harm product (orthopedic implant) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Smith & Nephew, Inc. is recalling 1,450 units of the R3 Zero Hole HA Coated Hemispherical Stiktite Coated Shell. These orthopedic implant components are available in sizes ranging from 42mm to 64mm and were 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 deviation or report any illnesses or injuries associated with the use of these devices.
Healthcare providers and patients who have received these specific devices should contact Smith & Nephew or their local distributor for instructions on how to proceed. The recall covers specific lot numbers associated with product reference numbers 71332242 through 71332264.
The recalled product
- Product
- smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM 7133
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 1,450
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)
- 71332242
- Lot Numbers: 18HM20693
- 18HM20693A 71332246
- Lot Numbers: 19EM17729
- 19EM17730
- 19EM17730A 71332248
- Lot Numbers: 18MM01856
- 19BM08386
- 19DM17884
- 19DM17885
- 19DM17890
- 19EM11946
- 19EM11947
- 19DM17881
- 18GM04752
- 18GM04753
- 18HM00807 71332250
- Lot Numbers: 18JM05436
- 18JM05435
- 18JM05436
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