—#159248

Product

DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 231220200 Item Number with the following Lot numbers 45785,46151, 47467, 48461, 48809, 100016 & 102325 231220202 Item Number with the following Lot Numbers: 45790, 48477, 48811, 100017, 101028 & 102338

Why it was recalled

A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On June 12, 2017, Zimmer Biomet distributed Urgent Medical Device Recall Removal and Certificates of Acknowledgement notices to their customers via email and FedEx. Risk Manager Customer Responsibilities are the following: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative and quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete and return the Certificate of Acknowledgement via email to: corporatequality.postmarket@zimmerbiomet.com and retain a copy in your records. 5. If after reviewing the notice and if you have further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com.

Recalling firm

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

Distribution

Distribution pattern: AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WV. Internationally to: Australia, Chile, Cost Rica, Ecuador, Netherlands, Panama & Switzerland

Timeline

Recall initiated: 2017-06-12
Terminated: 2018-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159248. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.