PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 15, 2020 Initiated: November 21, 2019 #Z-0781-2020

Product Description

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

Details

Recalling Firm
Stryker GmbH
Units Affected
N/A
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.
Location
Selzach, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by Stryker GmbH. Units affected: N/A.
Why was this product recalled?
Pin To Rod Coupling could not clamp the pin and rod as intended
Which agency issued this recall?
This recall was issued by the FDA Devices on January 15, 2020. Severity: Moderate. Recall number: Z-0781-2020.