# P030022: Reflection Ceramic Acetabular System

- Pathway: PMA
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 17, 2004 after 555 days
- Product code: MRA (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented)
- Device class: 3
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Mar 11, 2011 · Not classified · Z-2056-2011: During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. 
- Mar 11, 2011 · Not classified · Z-2055-2011: During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. 
- Mar 11, 2011 · Not classified · Z-2053-2011: During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. 
- Mar 11, 2011 · Not classified · Z-2057-2011: During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. 
- Mar 11, 2011 · Not classified · Z-2054-2011: During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. 
- Mar 11, 2011 · Not classified · Z-2058-2011: During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. 

Source page: https://510kreport.com/device/P030022
Methodology: https://510kreport.com/methodology