—#142307

Product

Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland

FDA product code: HAB — Saw, Powered, And Accessories
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Model # 01-8507-400-10 & Model # 89-8507-400-10

Why it was recalled

The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.

Root cause (FDA determination)

Device Design

Action the firm took

Zimmer sent an Urgent Medical Device Correction letter dated November 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Review this notification. 2. You will receive copies of notification sent directly to hospital risk managers and surgeons in your territory. As necessary, review and facilitate understanding of this notification by those entities. 3. Further identify hospital risk managers and/or surgeons in your territory who should also receive notification of this update, and supply the information to the entities you have identified. 4. If after reviewing this notification you have further questions or concerns, please call 330-364-0989 between the hours of 8 a.m. and 5 p.m. EST, Monday through Friday. Zimmer instructed their direct customers that they will upgrade the device with the new electronic during their annual preventative maintenance activities. Until the new upgrade is installed, the firm instructed their customers to follow the Instructions for Use.

Recalling firm

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

Distribution

Distribution pattern: US Distribution to the states of : AR, CA, CO, CT, FL, GA, HI, IL, KS, KY, LA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TX, UT, VA, WA, WI, WV and WY.

Timeline

Recall initiated: 2015-11-10
Posted by FDA: 2015-12-21
Terminated: 2016-02-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142307. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.