Recall Register

Food, drugs, devices › Wright Medical Technology, Inc.

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

FDA enforcement event 90660 · Class II · initiated 27 Jul 2022 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordMemphis, TN

Wright Medical Technology, Inc. (Memphis, TN) initiated this device recall on 27 Jul 2022; FDA lists 1 product record under event 90660, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Wright Medical Technology, Inc. has 26 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Wright Medical Technology, Inc., Memphis, TN.

Reason for recall

"An incorrect sizing label was applied to the carton packaging."

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 records

Recall numberProductQuantityClassStatusReport date
Z-1567-2022Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.17 devicesClass IIOngoing31 Aug 2022

Context

88%of 2022 device events are Class II839 events that year
1product record in this eventfirm median: 2
26events on this register for the firm

Other enforcement events for Wright Medical Technology, Inc.

InitiatedProduct (first record)TypeClassRecords
6 Mar 2024stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplastyDeviceClass II1
13 Jun 2023Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.DeviceClass II1
10 Apr 2023stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixationDeviceClass II2
2 Feb 2023ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation deviceDeviceClass II2
30 Sep 2022Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3DeviceClass II2
3 Aug 2022stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and RepairDeviceClass II2
14 Jun 2022Wright EVOLVE TRIAD Plate Cutter, REF 49510120DeviceClass II1
2 Jun 2022Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINIDeviceClass II1
10 Mar 2022EasyFuse Dynamic Compression System Instrument PackDeviceClass II1
15 Feb 2022Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORDeviceClass II1

All 26 events for Wright Medical Technology, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "An incorrect sizing label was applied to the carton packaging."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "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."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.