CLASS II ONGOING Device recall · Reported 12 Oct 2022 · FDA Enforcement Report
stryker Evolve, Proline Stem, CoCr, Size: +4, OD recalled
Wright Medical Technology is recalling stryker Evolve, Proline Stem, CoCr, Size: +4, OD, distributed nationwide in the US. The recall was initiated on 3 Aug 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-0006-2023
- FDA event ID
- 90772
- Recalling firm
- Wright Medical Technology, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Aug 2022
- FDA classified
- 4 Oct 2022
- Reported
- 12 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 3 Aug 2022 | Recall initiated by company | |
| 4 Oct 2022 | Classified by FDA | +62 days |
| 12 Oct 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.
Which lots are affected?
UDI/DI: (01)008404201856775(11)210831(17)290829 Lot Number 1704255
Where was it sold?
US Nationwide distribution.
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.
Other products in this recall event
1 other product · FDA event 90772| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | stryker Evolve, Proline Stem, CoCr, Size: +2, O recalled | Wright Medical Technology | Packaging Defects | Nationwide |
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 Infinity Alignment Frame Distal Sub-Assembly recalled | Wright Medical Technology | Device Malfunction | 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 |
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 |