Device recall: stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

Class II FDA enforcement event 94194. Recall start date: 6 Mar 2024. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.

Class II, in the words of FDA

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

Wright Medical Technology, Inc. started this device recall on 6 Mar 2024. The firm address in the FDA record is in Memphis, TN. FDA put the recall in Class II. FDA event 94194 has 1 product record. The first FDA enforcement report date is 10 Apr 2024. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK

Recalling firm

Wright Medical Technology, Inc., Memphis, TN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 94194: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1477-2024	stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty	47 units	Class II	Ongoing	10 Apr 2024

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2024: 970
Share of these events in Class II: 87%
Product records in this event: 1Median of the firm: 2
Events of the firm on the register: 26

Other events of the firm

Other FDA enforcement events of Wright Medical Technology, Inc.
Initiated	Product (first record)	Type	Class	Records
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
30 Sep 2022	Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3	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

Wright Medical Technology, Inc.: all 26 events

Official channels

FDA enforcement report Z-1477-2024The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 94194. https://recallregister.com/fda/ii/94194/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK
What quantity of product is in FDA event 94194?: The FDA record gives this quantity: 47 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2024 have the same class?: 87% of the 970 device events that started in 2024 are in Class II.