FDA recall Z-1522-2018

Zimmer Biomet, Inc. · Class II · device

Product

Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.

Reason for recall

There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.

Distribution

The product was distributed to the following states: CT, FL, GA, IN, MA, MI, NY, and TX. The product was distributed to the following countries: Malaysia and Netherlands.

Key facts

Status: Terminated
Initiation date: 2018-04-03
Report date: 2018-05-02
Termination date: 2018-07-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1522-2018