RecallRadar

FDA Device recall Z-1291-2022

Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle Syst…

On 2022-07-06 the FDA classified a Class II recall of Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle Syst… by Wright Medical Technology, citing the instrument is incorrectly color coded.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1291-2022
ClassificationClass II
Statusongoing
Initiated2022-06-02
Published2022-07-06
Last updated2026-09-13 11:56 UTC
CompanyWright Medical Technology
DistributionUS

Product

Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.

Reason

The instrument is incorrectly color coded.

Identifiers

code_infoLot #2039558, GTIN 00889797006552.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1291-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.