FDA recall Z-1191-2023

Product

stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved

Reason for recall

Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-02-07

Report date

2023-03-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Selzach, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1191-2023