Recall Z-0452-2016
Zimmer, Inc. · initiated November 10, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland
Codes / lots: Model # 01-8507-400-00 & Model # 89-8507-400-00
Reason for recall
The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0452-2016
- Initiated
- November 10, 2015
- Posted by FDA
- December 21, 2015
- Terminated
- February 19, 2016
- Product code
- HAB – Saw, Powered, And Accessories
- Quantity
- 87
- Distribution
- 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.
- Recalling firm
- Zimmer, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0453-2016 Class II | Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger…The firm identified a malfunction which made it possible for a handpiece to start by itself when the power… | 11/10/2015Terminated |