Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Published August 8, 2012 · Recall initiated: April 30, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Zimmer Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and the countries of Singapore, China, Hong Kong, Canada, Australia, Japan, Europe, Germany, India, and Finland.
- Lot
- Part 00-5901-026-00 Lot 11002148, 11002149, 11002791, 11002792, 11002831, 11003439, 11003449, 61800676, 61814993, 61909414, 61924920, 61980656, 61985378, 61988272, 61990656, 62003795, 62011220, 77000065, 77000573, 77000574, 77000575, 77000583, 77000654, 77000786, 77000787, 77000788, 77000789, 77000790, 77000795, 77000797, 77000798, 77000799, 77000804, 77000848, 77000849, 77000872, 77000873, 77001039, 77001048, 77001096, 77001097, 77001118, and 77001119
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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