—#171355

Product

Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989

FDA product code: KIH — Dispenser, Cement
Device class: Class 1
Medical specialty: Orthopedic
510(k) numbers: K033280
Affected lot / code info: All lots

Why it was recalled

Lack of an adequate sterilization validation

Root cause (FDA determination)

Process design

Action the firm took

Zimmer Biomet issued recall letter on 2/28/19 via FedEx and email identifying reason for recall to the consumer/user level, including any intermediate wholesale or retail consignees. Distributors responsibilities include locating and removing the product in their territory, as well as identifying hospitals and surgeons who have previously used the product. " Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. " Surgeons provided with a letter that identifies the issue and their responsibilities, which include: - Following any specified patient monitoring instructions - Returning Certificate of Acknowledgment to Zimmer Biomet. " Hospital risk managers provided with a letter identifying the issue and their responsibilities. Questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2019-02-28
Terminated: 2020-04-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171355. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.