FDA recall Z-2647-2017

Product

ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E

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-2647-2017