Z-0111-2015 Class II Terminated
FDA device recall Z-0111-2015 was initiated by Signal Medical Corporation on September 30, 2014 and is designated Class II. Reason for recall: Packaging of a device was compromised The recall status is terminated (terminated March 14, 2016). Affected quantity: 41.
Recall Details
- Product Type
- Devices
- Report Date
- October 29, 2014
- Initiation Date
- September 30, 2014
- Termination Date
- March 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41
Product Description
Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
Reason for Recall
Packaging of a device was compromised
Distribution Pattern
Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.
Code Information
Catalog # 22-01-02106; Lot # 1110; Serial # L0259; Size 6R Catalog #22-01-02106; Lot # 2910; Serial # L0533; Size 6R Catalog # 22-01-02003, Serial #s L0280,L0283, L0284, L0285, L0287, L0288, L0615, Size 3 L Catalog # 22-01-02004, Serial # l0358, Size 4L Catalog # 22-01-02005, Serial # L0809; Size 5L Catalog #22-01-02006; Serial #s L0692, L0842, L0485, L0483, L0486, L0841, L0844, L0847, Size 6L Catalog # 22-01-02007, Serial #s L0721, L0786, L0787, L0770, L0772, L0775, Size 7L Catalog #22-01-02103, Serial #s L0265, L0272, Size 3R Catalog # 22-01-02104, Serial #s L0479, L0515, L0517, Size 4R Catalog # 22/01-02106, Serial # L0338, L0508, L0537, L0853, L0867, L0872, L0873, Size 6R Catalog #22-01-02107, Serial #s L0749, L0758, L0760, L0755, L0759, L0762, Size 7R