Z-2989-2020Class II

EVOLVE STEM 8.5MM Model # 496S085

Name: Z-2989-2020 EVOLVE STEM 8.5MM Model # 496S085
Creator: Wright Medical Technology Inc
Published: 2020-08-26
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2020-08-26 / Terminated / root cause: manufacturing process

FDA source

Wright Medical Technology Inc began a recall of EVOLVE STEM 8.5MM Model # 496S085 on 2020-08-26. FDA classified it as Class II and gives the reason as "Lack of sterility assurance". 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-2989-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-26
Posted: 2020-09-21
Terminated: 2021-04-27
Recalling firm: Wright Medical Technology Inc
Product: EVOLVE STEM 8.5MM Model # 496S085
Product code: KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Reason for recall: Lack of sterility assurance
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Wright initiated a recall on 08/26/2020. It states the following: 1. Immediately cease all use and distribution of this affected lot 2. Immediately quarantine all recalled products you have found, and return all affected product to Wright Medical as soon as possible. 3. Contact Customer Service at 800-238-7117 for return instructions and replacement inventory. 4. If you have further distributed the affected product, please notify the applicable parties . You may copy and distribute this letter and Wright Medical will work directly with them to collect the recalled items. 5. Wright asks you to complete, sign, and return the form as soon as possible. Please return the completed acknowledgement to Wright Medical via email to: [email protected] within five (5) working days of this notice. If you have further questions, or are aware of any patient issues with these lots, please do not hesitate to contact Customer Service at Wright Medical at 800-238-7117 for more information.
Quantity in commerce: 16 stems
Distribution: USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain
Product codes and lots: Lot # 1668777

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2989-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2989-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-21

Product code KWI

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)