FDA Device Recalls

Recalls / —

—#195354

Product

Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.

FDA product code
MPK — Semi-Constrained Metal/Polymer Finger Joint Prosthesis
Device class
Class f
Medical specialty
Unknown
Affected lot / code info
Lot numbers 1728375 and 1728376, UDI #00840420121707.

Why it was recalled

An incorrect sizing label was applied to the carton packaging.

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm
Wright Medical Technology, Inc.
Address
1023 Cherry Rd, Memphis, Tennessee 38117-5423

Distribution

Distribution pattern
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.

Timeline

Recall initiated
2022-07-27
Status
—

Source: openFDA Device Recall endpoint. Recall record ID #195354. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.