Z-2949-2018 Class II Terminated
FDA device recall Z-2949-2018 was initiated by DePuy Orthopaedics, Inc. on Jul 18, 2018 and is designated Class II. Reason for recall: This unit may be missing the screw/collet Assembly The recall status is terminated (terminated Apr 17, 2019). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 5, 2018
- Initiation Date
- Jul 18, 2018
- Termination Date
- Apr 17, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Reason for Recall
This unit may be missing the screw/collet Assembly
Distribution Pattern
The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain.
Code Information
Lot: C2KJ24, GTIN: 10603295234135
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2949-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026