EVOLVE STEM 8.5MM Model # 496S085
FDA Recall Z-2989-2020 · Posted None
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Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeKWI
Date Initiated2020-08-26
Date Terminated2021-04-27
Product Quantity16 stems
Reason for Recall
Lack of sterility assurance
Firm 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.
Root Cause
Process control
Distribution Pattern
USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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