X-Change recallZ-0514-2020 · Howmedica Osteonics Corp. · initiated Oct 3, 2019
Terminated
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 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
Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)
FDA root cause category: Employee error
What the company is doing
Stryker issued An Urgent Field Safety Notice (FSN), PFA 2197654, was issued to all affected OUS consignees at country level on October 03, 2019. Action to take: Actions to be taken by the Customer/ User: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. A response is required, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Complete customer response form and return the form and any affected devices to the following address. (Please complete this form regardless of whether your organization has product to return. This will preclude the need for Stryker to send any reminder notice.) ATTN: David Nihill, Limerick Finished Goods Centre C/O Flextronics Global Services Ireland Unit 1 Raheen Business Park Raheen, Limerick.
Recall details
- Recall number
- Z-0514-2020
- Status
- Terminated
- Initiated by the company
- Oct 3, 2019
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 40 units
- Product code
- LPH
- FDA submissions
- K121308
- Distribution
- Foreign: Australia, France, Finland, Germany, Italy, Japan, New Zealand, Netherlands, Norway, Romania, Spain, Sweden and UK
Product description
Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
Code information (models, lots, serial numbers)
Lot Number: G6091225, Exp. Date: 2022-06 UDIs: (01)04546540167712(17)220618(10)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- X-Change 0942-8-025Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall1 report
Product lines
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 16, 2026. Text above is shown as published by the FDA.
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