R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM… recallZ-1928-2013 · Smith & Nephew Inc · initiated May 29, 2013
Class II Terminated All recalls posted in August 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.
FDA root cause category: Packaging process control
What the company is doing
All affected Smith & Nephew Sales Representatives were notified of problem and the recall via email on 5/29. They were instructed to cease use and distribution of the product and quarantine for return. Surgeons were notified by letter beginning on 6/12. International consignees were notified on 05/29 via email.
Recall details
- Recall number
- Z-1928-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 29, 2013
- Posted by the FDA
- Aug 8, 2013
- Recalling firm
- Smith & Nephew Inc
- Quantity
- 53 units
- Product code
- MBL
- FDA submissions
- K113848
- Distribution
- Worldwide Distribution-USA including the states of PA, WA, TX, FL, IA, MI, WI, TN, KY, IN, NY, MO and OR, and the countries of India, Canada, Chile, Venezuela, Dubai, South Africa, Australia, Poland, Romania, Belgium, Germany and United Kingdom.
Product description
R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.
Code information (models, lots, serial numbers)
Batch No. 12FM00603
Other devices under the same FDA submission
47 devices cleared under K113848 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- R3 71335752Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented43 reports
- R3 71335754Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented33 reports
- R3 71335756Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented31 reports
- R3 71337650Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented28 reports
- R3 71337648Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented23 reports
- R3 71332756Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented22 reports
- R3 71332754Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented21 reports
- R3 71332752Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented20 reports
- R3 71339550Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented20 reports
- R3 71339548Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented14 reports
- R3 71337652Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented13 reports
- R3 71334946Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented12 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 65370).
- Z-1929-2013 · TerminatedR3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page