CLASS II ONGOING Device recall · Reported 12 Jul 2023 · FDA Enforcement Report
Stryker Infinity Alignment Frame Distal Sub-Assembly recalled
Wright Medical Technology is recalling Stryker Infinity Alignment Frame Distal Sub-Assembly. The recall was initiated on 13 Jun 2023 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-2105-2023
- FDA event ID
- 92460
- Recalling firm
- Wright Medical Technology, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Jun 2023
- FDA classified
- 6 Jul 2023
- Reported
- 12 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 13 Jun 2023 | Recall initiated by company | |
| 6 Jul 2023 | Classified by FDA | +23 days |
| 12 Jul 2023 | 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
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot numbers 2656815 and 2762126, UDI-DI 00889797003926.
Where was it sold?
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.
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.
More recalls from Wright Medical Technology
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Charlotte Claw Screw recalled by Wright Medical Technology | Wright Medical Technology | Other | Nationwide |
| Device | CLASS II | stryker Infinity Resection Adjustment Block recalled | Wright Medical Technology | Other | NE, TX |
| 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 |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |