—#158369

Product

NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 3.5 mm Diameter 195 mm Length, Item Number/EDI 0200024325, Nonsterile. orthopedic surgical instrument.

FDA product code: HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Numbers: 63385956, 63405774 & 63445667

Why it was recalled

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Root cause (FDA determination)

Process control

Action the firm took

On 5/22/2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers and distributors. On 12/19/2017, Zimmer Biomet sent Urgent Medical Device Recall notices to their customers due to a recall expansion involving one (1) lot for product # 20. Customers are advised to review the notice and ensure that affected personnel are aware of the contents. All stock should be inspected and product quarantined. A Zimmer Biomet sales representative will remove the affected product from your facility. Customers should complete and return the Certificate of Acknowledgement via email to: corporatequality.postmarket@zimmerbiomet.com and retain the copy for your files. Customers with questions may call the customer call center at 574-371-3071, Monday through Friday 8 am - 5 pm, EST. *For Distributors Your Responsibilities include the following: 1. Review this notification and ensure affected team members 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. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com 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. a. For each return, send a copy of the completed acknowledgement form via email to: corporatequality.postmarket@zimmerbiomet.com. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Include a copy of Attachment 3 Certificate of Sterilization with returned instruments. d. Mark the outside of the returns box(es) clearly with FIELD ACTION. 5. Note that any hospitals that received direct shipments of this product from Zimmer Biomet will be sent a copy of the Risk Manager Field Action Notice direc

Recalling firm

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

Distribution

Distribution pattern: Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

Timeline

Recall initiated: 2017-05-22
Posted by FDA: 2017-09-22
Terminated: 2019-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #158369. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.