RecallRadar

FDA Device recall Z-0772-2021

Bone fixation nail

On 2021-01-13 the FDA classified a Class II recall of Bone fixation nail by Smith And Nephew, citing manufacturing packaging error.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0772-2021
ClassificationClass II
Statusterminated
Initiated2020-11-02
Published2021-01-13
Last updated2026-09-13 11:56 UTC
CompanySmith And Nephew
DistributionUS

Product

Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;

Reason

Manufacturing packaging error.

Identifiers

code_infoModel #: 71675535 & 71675532 Lot #: 20CM25278 & 20DM01466.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0772-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.