# P020016: Walter Lorenz Total Temporomandibular Joint Replacement System

- Pathway: PMA
- Applicant: Biomet Microfixation, Inc.
- Decided: Sep 21, 2005 after 1,227 days
- Product code: LZD (Joint, Temporomandibular, Implant)
- Device class: 3
- Regulation: 21 CFR 872.3940
- Recalls of this device: 17 (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
- Oct 17, 2014 · Class II · Z-0510-2015: Laser etching on the parts is wider and deeper than the conditions previously validated.
- Oct 17, 2014 · Class II · Z-0514-2015: Laser etching on the parts is wider and deeper than the conditions previously validated.
- Oct 17, 2014 · Class II · Z-0515-2015: Laser etching on the parts is wider and deeper than the conditions previously validated.
- Oct 17, 2014 · Class II · Z-0519-2015: Laser etching on the parts is wider and deeper than the conditions previously validated.
- Oct 17, 2014 · Class II · Z-0513-2015: Laser etching on the parts is wider and deeper than the conditions previously validated.
- Oct 17, 2014 · Class II · Z-0512-2015: Laser etching on the parts is wider and deeper than the conditions previously validated.
- Oct 17, 2014 · Class II · Z-0518-2015: Laser etching on the parts is wider and deeper than the conditions previously validated.
- Oct 17, 2014 · Class II · Z-0509-2015: Laser etching on the parts is wider and deeper than the conditions previously validated.
- Oct 17, 2014 · Class II · Z-0511-2015: Laser etching on the parts is wider and deeper than the conditions previously validated.
- Oct 17, 2014 · Class II · Z-0516-2015: Laser etching on the parts is wider and deeper than the conditions previously validated.
- Oct 17, 2014 · Class II · Z-0517-2015: Laser etching on the parts is wider and deeper than the conditions previously validated.
- Oct 17, 2014 · Class II · Z-0520-2015: Laser etching on the parts is wider and deeper than the conditions previously validated.
- Oct 17, 2014 · Class II · Z-0521-2015: Laser etching on the parts is wider and deeper than the conditions previously validated.
- Oct 17, 2014 · Class II · Z-0522-2015: Laser etching on the parts is wider and deeper than the conditions previously validated.
- Sep 20, 2013 · Class II · Z-2566-2014: Product mix occurred prior to final package and labeling process.
- Apr 7, 2010 · Not classified · Z-0822-2012: Biomet Microfixation, Inc., Jacksonville, FL recalled Part # 24-6546, 45mm Left Standard Mandible and Part # 24-6646, 45mm Left Standard Offset Mandible due to a lot of 24-6246 being etched & labeled 
- Apr 7, 2010 · Not classified · Z-0823-2012: Biomet Microfixation, Inc., Jacksonville, FL recalled Part # 24-6546, 45mm Left Standard Mandible and Part # 24-6646, 45mm Left Standard Offset Mandible due to a lot of 24-6246 being etched & labeled 

Source page: https://510kreport.com/device/P020016
Methodology: https://510kreport.com/methodology