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

Device recall: Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3

FDA enforcement event 90965 · Class II · initiated 30 Sep 2022 · status Terminated · terminated 21 Aug 2026

DeviceVoluntary: Firm initiated2 product recordsMemphis, TN

Wright Medical Technology, Inc. (Memphis, TN) initiated this device recall on 30 Sep 2022; FDA lists 2 product records under event 90965, 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: Terminated, terminated 21 Aug 2026. 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

"The tibial tray lock detail is oversized (larger than specification)."

Distribution

"US Nationwide distribution in the state of New York."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0139-2023	Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3	1 unit	Class II	Terminated	2 Nov 2022
Z-0140-2023	Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4	1 unit	Class II	Terminated	2 Nov 2022

Context

88%of 2022 device events are Class II839 events that year

2product records in this eventfirm median: 2

26events on this register for the firm

Other enforcement events for Wright Medical Technology, Inc.

Initiated	Product (first record)	Type	Class	Records
6 Mar 2024	stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty	Device	Class II	1
13 Jun 2023	Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.	Device	Class II	1
10 Apr 2023	stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation	Device	Class II	2
2 Feb 2023	ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device	Device	Class II	2
3 Aug 2022	stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair	Device	Class II	2
27 Jul 2022	Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.	Device	Class II	1
14 Jun 2022	Wright EVOLVE TRIAD Plate Cutter, REF 49510120	Device	Class II	1
2 Jun 2022	Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINI	Device	Class II	1
10 Mar 2022	EasyFuse Dynamic Compression System Instrument Pack	Device	Class II	1
15 Feb 2022	Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the OR	Device	Class II	1

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: "The tibial tray lock detail is oversized (larger than specification)."

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: "US Nationwide distribution in the state of New York."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 21 Aug 2026. "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.