CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report
Wright Evolve Proline Head, Size: +2, OD recalled
Wright Medical Technology is recalling Wright Evolve Proline Head, Size: +2, OD. The recall was initiated on 27 Dec 2019 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-1101-2020
- FDA event ID
- 84673
- Recalling firm
- Wright Medical Technology, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Dec 2019
- FDA classified
- 6 Feb 2020
- Reported
- 12 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 27 Dec 2019 | Recall initiated by company | |
| 6 Feb 2020 | Classified by FDA | +41 days |
| 12 Feb 2020 | 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
Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
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
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
Where it was distributed
US
Questions about this recall
Why was it recalled?
Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
Which lots are affected?
Lot Code 1633010
Where was it sold?
US
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 84673| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Wright Evolve Proline Head, Size: +2, OD recalled | Wright Medical Technology | Packaging Defects | TN |
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