Z-1567-2022Class II

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

Name: Z-1567-2022 Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile
Creator: Wright Medical Technology, Inc.
Published: 2022-07-27
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2022-07-27 / Open, Classified / root cause: labeling and UDI

FDA source

Wright Medical Technology, Inc. began a recall of Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile on 2022-07-27. FDA classified it as Class II and gives the reason as "An incorrect sizing label was applied to the carton packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1567-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-27
Posted: 2022-08-23
Recalling firm: Wright Medical Technology Inc
Product: Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
Product code: MPK Semi-Constrained Metal/Polymer Finger Joint Prosthesis
Reason for recall: An incorrect sizing label was applied to the carton packaging.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: 17 devices
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 codes and lots: Lot numbers 1728375 and 1728376, UDI #00840420121707.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1567-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1567-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-23

Product code MPK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)