CLASS II ONGOING Device recall · Reported 10 Apr 2024 · FDA Enforcement Report
stryker Infinity Resection Adjustment Block recalled
Wright Medical Technology is recalling stryker Infinity Resection Adjustment Block, distributed in Nebraska, Texas. The recall was initiated on 6 Mar 2024 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-1477-2024
- FDA event ID
- 94194
- Recalling firm
- Wright Medical Technology, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Mar 2024
- FDA classified
- 4 Apr 2024
- Reported
- 10 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 6 Mar 2024 | Recall initiated by company | |
| 4 Apr 2024 | Classified by FDA | +29 days |
| 10 Apr 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Where it was distributed
US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK
Questions about this recall
Is stryker Infinity Resection Adjustment Block recalled?
Yes. Wright Medical Technology recalled stryker Infinity Resection Adjustment Block on 6 Mar 2024. The recall is Class II and its status is Ongoing. Recall number Z-1477-2024.
Why was it recalled?
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.
Which lots are affected?
UDI/DI 00889797004008, Lot Numbers: 2656950, 2762126, 2796094
Where was it sold?
US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Wright Medical Technology
All 78| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stryker Infinity Alignment Frame Distal Sub-Assembly recalled | Wright Medical Technology | Sterility | TN |
| Device | CLASS II | stryker Ortholoc 3Di Fusion Plate MTP Right recalled | Wright Medical Technology | Other | Nationwide |
| Device | CLASS II | stryker Ortholoc 3Di Fusion Plate MTP Right recalled | Wright Medical Technology | Other | Nationwide |
| Device | CLASS II | Ortholoc 3DSi Claw II 4 Hole Plate, Size recalled | Wright Medical Technology | Packaging Defects | Nationwide |
| Device | CLASS II | Ortholoc 3DSi Claw II 4 Hole Plate, Size recalled | Wright Medical Technology | Packaging Defects | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |