PMA · Approved
Recalled · Class II · 2014Walter Lorenz Total Temporomandibular Joint Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Microfixation, Inc. · LZD Joint, Temporomandibular, Implant
Approved on Sep 21, 2005 through premarket approval, which rests on the device’s own clinical evidence after a 1,227-day review. It has been recalled 17 times.
- Decided
- Sep 21, 2005
- Review
- 1,227 days
- Class
- Class III
- Product code
- LZD
- Recalls
- 17
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P020016 has 11 supplements since 2006: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2006 | 2 |
| 2009 | 1 |
| 2010 | 2 |
| 2012 | 1 |
| 2014 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2026 | 2 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 17, 2014 | Class II | Z-0510-2015 | Software Design Change | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Oct 17, 2014 | Class II | Z-0514-2015 | Software Design Change | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Oct 17, 2014 | Class II | Z-0515-2015 | Software Design Change | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Oct 17, 2014 | Class II | Z-0519-2015 | Software Design Change | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Oct 17, 2014 | Class II | Z-0513-2015 | Software Design Change | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Oct 17, 2014 | Class II | Z-0512-2015 | Software Design Change | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Oct 17, 2014 | Class II | Z-0518-2015 | Software Design Change | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Oct 17, 2014 | Class II | Z-0509-2015 | Software Design Change | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Oct 17, 2014 | Class II | Z-0511-2015 | Software Design Change | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Oct 17, 2014 | Class II | Z-0516-2015 | Software Design Change | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Oct 17, 2014 | Class II | Z-0517-2015 | Software Design Change | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Oct 17, 2014 | Class II | Z-0520-2015 | Software Design Change | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Oct 17, 2014 | Class II | Z-0521-2015 | Software Design Change | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Oct 17, 2014 | Class II | Z-0522-2015 | Software Design Change | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Sep 20, 2013 | Class II | Z-2566-2014 | Mixed-up of materials/components | Product mix occurred prior to final package and labeling process. |
| Apr 7, 2010 | Not classified | Z-0822-2012 | Employee error | 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 as 24-6646 and the reverse, a lot of… |
| Apr 7, 2010 | Not classified | Z-0823-2012 | Employee error | 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 as 24-6646 and the reverse, a lot of… |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LZD devicesLZD Joint, Temporomandibular, Implant: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZD
Too few LZD 510(k)s in any year since 2007 to give a median.
Recalls per year · LZD
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LZD
226in 2025
MAUDE reports naming product code LZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 22 |
| 2008 | 0 | — | 0 | 22 |
| 2009 | 2 | — | 0 | 32 |
| 2010 | 2 | — | 0 | 49 |
| 2011 | 0 | — | 0 | 69 |
| 2012 | 5 | — | 0 | 73 |
| 2013 | 0 | — | 0 | 104 |
| 2014 | 3 | — | 14 | 96 |
| 2015 | 1 | — | 0 | 146 |
| 2016 | 0 | — | 0 | 131 |
| 2017 | 1 | — | 0 | 95 |
| 2018 | 0 | — | 0 | 210 |
| 2019 | 1 | — | 0 | 204 |
| 2020 | 2 | — | 0 | 255 |
| 2021 | 1 | — | 0 | 207 |
| 2022 | 1 | — | 0 | 193 |
| 2023 | 1 | — | 0 | 236 |
| 2024 | 2 | — | 0 | 207 |
| 2025 | 1 | — | 1 (1) | 226 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/P020016 · printed Nov 3, 2026
Cite this page
510(k) Report. “P020016: Walter Lorenz Total Temporomandibular Joint Replacement System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/P020016
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026