Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1133-2022

April 22, 2022

Class II

Product summary

Firm
Smith & Nephew Orthopaedics GmbH
Event
Event 90118
Status
Ongoing
Classification
Class II
Quantity
17 units
Official record key
device-enforcement:Z-1133-2022

Official wording

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

Code information: Product number: 71676627 (DI: 00885556131633), Batch Number: 21LT56988; 71676628 (DI: 00885556040027), Batch number: 21LT56989

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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