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Z-1510-2022 Class II Ongoing

Recalled by Medical Modeling, Inc. — Littleton, CO

FDA device recall Z-1510-2022 was initiated by Medical Modeling, Inc. on May 17, 2022 and is designated Class II. Reason for recall: Scapula Marking Guide (anatomically Shaped) was incorrectly designed. The recall status is ongoing. Affected quantity: 1 unit.

Recall Details

Product Type: Devices
Report Date: August 17, 2022
Initiation Date: May 17, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1 unit

Product Description

3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile

Reason for Recall

Scapula Marking Guide (anatomically Shaped) was incorrectly designed.

Distribution Pattern

International distribution in the country of Germany.

Code Information

Lot # 167559; UDI: (01) 00816847020886