Z-1102-2020Class II

WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222

Name: Z-1102-2020 WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
Creator: Wright Medical Technology, Inc.
Published: 2019-12-27
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2019-12-27 / Terminated / root cause: manufacturing process

FDA source

Wright Medical Technology, Inc. began a recall of WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222 on 2019-12-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1102-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-27
Posted: 2020-02-06
Terminated: 2021-07-23
Recalling firm: Wright Medical Technology Inc
Product: WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
Product code: KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by email and letter on 12/27/2019. The notices requests the following actions: Immediately quarantine all recalled products they have and return all affected product to Wright Medical as soon as possible. If they have further distributed the affected product, we are asking them to notify the applicable parties at once about this recall. They may copy and distribute the notification letter and Wright Medical will work directly with them to collect the recalled items.
Quantity in commerce: 48 devices
Distribution: US
Product codes and lots: Lot code 1633303

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1102-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1101-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-06
Z-1102-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-06

Product code KWI

K060731Class IIEvolve Modular Radial HeadWrightmedicaltechnologyinc / cleared 2006-04-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)