FDA recall Z-1133-2022

Smith & Nephew Orthopaedics GmbH · Class II · device

Product

INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right

Reason for recall

Right nails were anodized, marked, and labelled as left nails and vice versa

Distribution

Distributed nationwide to GA, OH, IN, TX, CO, MO, TN, CA, NC, PA and internationally to Canada, Australia.

Key facts

Status
Ongoing
Initiation date
2022-04-22
Report date
2022-06-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tuttlingen, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1133-2022