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Recall Observatory FDA recall evidence

Device 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

Z-0781-2020

November 21, 2019

Class II

Product summary

Firm
Stryker GmbH
Event
Event 84451
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0781-2020

Official wording

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

Code information: Lot Number: D30875 UDI : (01)07613327089158(10)D30875

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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