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Terminated

Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty

FDA Recall Z-1011-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeMBH
Date Initiated2017-10-03
Date Terminated2018-08-23
Product Quantity8

Reason for Recall

The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.

Firm Action

The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL REMOVAL" letter dated October 3, 2017 to distributors and customers. The letter described the product, problem and actions to be taken. The customers were instructed to: 1. Review notification and ensure affected team member are aware of the contents 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form via digital copy to: [email protected] within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet via SMS, via email to: [email protected] "RECALL" as RGA type. 5. Identify additional accounts Zimmer Biomet has not notified. 6. Retain a copy of your recall acknowledgement and product return forms for your records. Questions or concerns can be directed to the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.

Root Cause

Error in labeling

Distribution Pattern

US Distribution to states of: FL, WI, MD, MO, and MI.

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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