Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular… recallZ-0192-2012 · Stryker Howmedica Osteonics Corp. · initiated Jun 3, 2011
Terminated All recalls posted in November 2011
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 Stryker Howmedica Osteonics Corp. 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
Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used.
FDA root cause category: Labeling False and Misleading
What the company is doing
The firm, Stryker, sent an "URGENT PRODUCT CORRECTION" letter and Product Correction Bulletin dated June 3, 2011 via Fed Ex to its customers. The letter and bulletin describes the issue, potential hazards, risk mitigation and product correction instructions. The customers were instructed to complete and return the enclosed PRODUCT CORRECTION ACKNOWLEDGMENT FORM within 5 days via fax to: 201-831-6069. If you have any questions, feel free to call (201) 972-2100 or Hip Marketing Team at 201-831-5280.
Recall details
- Recall number
- Z-0192-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 3, 2011
- Posted by the FDA
- Nov 16, 2011
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 1951 units
- Product code
- LZO
- FDA submissions
- K103233
- Distribution
- Nationwide distribution.
Product description
Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France The MDM Liner and X3 Acetabular Inserts is a sterile single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica osteonics 22.2 mm and 28 mm diameter femoral heads.
Code information (models, lots, serial numbers)
Catalog No. 626-00-XXY (XXY= 36C, 38D, 42E, 46F, 48G, 52H, 54I, 58J) All lots K103233
Other devices under the same FDA submission
2 devices cleared under K103233 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- X3 1236-2-244Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate30 reports
- X3 1236-2-242Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate3 reports
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.
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