Recall Z-0781-2020— Stryker GmbH

Name: FDA recall Z-0781-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-21

Class II · Terminated

Class II FDA medical device recall by Stryker GmbH, initiated 2019-11-21, terminated 2020-11-13. It names one FDA 510(k) clearance: K102885. 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: Pin To Rod Coupling could not clamp the pin and rod as intended.

Recalling firm: Stryker GmbH
Classification: Class II
Status: Terminated
Initiated: 2019-11-21
Terminated: 2020-11-13
Firm location: Selzach, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K102885 — HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EXStryker Corp.·cleared 2011-01-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.