FDA recall Z-2646-2017

Product

ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E

Reason for recall

The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm

Distribution

AZ, IL & KS

Key facts

Status

Terminated

Initiation date

2017-05-23

Report date

2017-07-05

Termination date

2018-06-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2646-2017