Recall archive / FDA device enforcement
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile. — FDA record Z-2105-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 13, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
- Reason
- The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.
- Classification
- Class II
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 106 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2105-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot numbers 2656815 and 2762126, UDI-DI 00889797003926. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 12, 2023
- Recall initiation date
- Jun 13, 2023
- Center classification date
- Jul 6, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.