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

Lot, batch or date codesLot code 1633303

Quantity recalled48 devices

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-1102-2020
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: 22mm, REF 496H222

Where it was distributed

Questions about this recall

Is Wright Evolve Proline Head, Size: +2, OD recalled?

Yes. Wright Medical Technology recalled Wright Evolve Proline Head, Size: +2, OD on 27 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-1102-2020.

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 1633303

Where was it sold?

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.

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