Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Spec

FDA device recall Z-2569-2017 · posted 2017-03-20 · Terminated

Recall details

Recalling firm

Zimmer Biomet, Inc.

Reason for recall

Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.

Action taken

Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following: 1. Review this notification and ensure affected team members are aware of the contents. 2. Complete the Certification of Acknowledgement portion of Attachment 1 a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 3. Assist the Zimmer Biomet sales representative quarantine all affected product. 4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax. Online: www.fda.gov/medwatch/report.htm Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm Fax: 1-800-FDA-0178 Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing zimmer.per@zimmerbiomet.com. For questions regarding this recall call 574-371-3071.

Root cause

Packaging

Status

Terminated

Product code

KRO

Quantity affected

9867

Distribution

Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jo

Date initiated

2017-02-28

Date posted

2017-03-20

Date terminated

2018-02-27

Location

Warsaw, IN

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