FDA recall Z-0781-2020

Product

Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity fractures Radial osteotomies Foot and ankle fractures Paediatric fractures

Reason for recall

Pin To Rod Coupling could not clamp the pin and rod as intended

Distribution

Worldwide distribution - US Nationwide distribution including states of FL, MA, MI, NC, NJ, TX, WA, and countries of Brazil, Italy, South Africa, Netherlands, Spain, and China.

Key facts

Status

Terminated

Initiation date

2019-11-21

Report date

2020-01-15

Termination date

2020-11-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Selzach, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0781-2020