CLASS II ONGOING Device recall · Reported 6 Jul 2022 · FDA Enforcement Report
Stryker Infinity Resect Guide for Inbone Talus, Size recalled
Wright Medical Technology is recalling Stryker Infinity Resect Guide for Inbone Talus, Size 4, distributed nationwide in the US. The recall was initiated on 2 Jun 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1291-2022
- FDA event ID
- 90216
- Recalling firm
- Wright Medical Technology, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Jun 2022
- FDA classified
- 27 Jun 2022
- Reported
- 6 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 2 Jun 2022 | Recall initiated by company | |
| 27 Jun 2022 | Classified by FDA | +25 days |
| 6 Jul 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The instrument is incorrectly color coded.
Product as listed by the FDA
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL, MA, MI, MN, MO, NC, NY, OH, PA, TX, and WA. The countries of Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Sweden, Switzerland, and United Kingdom.
Nationwide ArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisMassachusettsMichiganMinnesotaMissouriNorth CarolinaNew YorkOhioPennsylvaniaTexasWashington
Questions about this recall
Why was it recalled?
The instrument is incorrectly color coded.
Which lots are affected?
Lot #2039558, GTIN 00889797006552.
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL, MA, MI, MN, MO, NC, NY, OH, PA, TX, and WA. The countries of Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Sweden, Switzerland, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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