Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Enforcement
- Recall Number
- Z-2092-2012
- Event ID
- 61764
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zimmer Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- August 8, 2012
- Initiation Date
- April 30, 2012
- Classification Date
- July 27, 2012
- Termination Date
- June 4, 2014
- Address
- 345 E Main St, N/A, Warsaw, IN, 46580-2746, United States
Description
Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off of the instrument during use, and a device fragment may be left in the surgical site. The risk of disassembly or fracture occurs when the instrument is typicall
Part 00-5901-026-40 Lot 62011774, 61870067, and 61813699 Initially the 00-5901-026-40 replacement jaws will remain available for order until all of the alternative instruments are in place, however they will also be required to be returned. The final lot numbers and manufacture dates will be provided in a subsequent status update.
Worldwide Distribution - USA (nationwide) and the countries of Singapore, China, Hong Kong, Canada, Australia, Japan, Europe, Germany, India, and Finland.
65 units