—#153881

Product

Segmental fluted stem, 18x250mm bwd, Sterile,

FDA product code: KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K070978
Affected lot / code info: Item Number: 00585205418, Lot Number Expiry Date Before: July 2026

Why it was recalled

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.

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand

Timeline

Recall initiated: 2017-02-28
Posted by FDA: 2017-03-20
Terminated: 2018-02-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153881. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.