SWANSON recallZ-1567-2022 · Wright Medical Technology, Inc. · initiated Jul 27, 2022
Open, Classified
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 Wright Medical Technology, 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
An incorrect sizing label was applied to the carton packaging.
FDA root cause category: Error in labeling
What the company is doing
The recalling firm issued letters dated 7/27/2022 to Health Care Professionals, Operators of Medical Devices, and Distributors. Distributors received the letter via email. The medical facility received the letter via FedEx. The letter informed the consignee of the product affected, product description, product issue, potential risks, and the actions needed by customers and distributors. The actions included (1) Immediately check their internal inventory to locate the product and remove it from their point of use and isolate/quarantine it to prevent accidental usage; (2) Return the enclosed business reply form by email to confirm receipt of the notification and document product segregation. The form is to be returned by 8/10/2022; (3) Return all affected product in their possession. Hospitals are instructed to contact their local sales office or Stryker sales representative directly for product returns and inventory questions. Branches/Hub are to return the affected devices to the address specified in the letter; (4) Ensure that personnel within the facility are aware of this communication and all required actions are completed; and (5) If product has been further distributed, notify the applicable parties at once regarding the recall.
Recall details
- Recall number
- Z-1567-2022
- Status
- Open, Classified
- Initiated by the company
- Jul 27, 2022
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 17 devices
- Product code
- MPK
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, GA, NY, PA, and TN. The countries of the Australia, France, the Netherlands, Sweden, and the United Kingdom.
Product description
Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
Code information (models, lots, serial numbers)
Lot numbers 1728375 and 1728376, UDI #00840420121707.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SWANSON 4700020Wright Medical Technology, Inc. · PROSTHESIS, FINGER, POLYMER1 recall0 reports
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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