Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
- 510(k)K172408Substantially equivalent (SESE) · 2017-10-05clearance family
Predicate lineage
- K172408
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-11-09 | VAI | Voluntary action indicated | Biomet, Inc. | 0 |
| 2023-11-09 | VAI | Voluntary action indicated | Biomet, Inc. | 0 |
| 2020-01-30 | VAI | Voluntary action indicated | Biomet, Inc. | 8 |
| 2020-01-30 | VAI | Voluntary action indicated | Biomet, Inc. | 8 |
| 2018-08-24 | WL | Warning Letter | Biomet, Inc. | — |
| 2018-08-24 | WL | Warning Letter | Biomet, Inc. | — |
| 2018-04-24 | OAI | Official action indicated | Biomet, Inc. | 11 |
| 2018-04-24 | OAI | Official action indicated | Biomet, Inc. | 11 |
| 2017-08-17 | NAI | No action indicated | Zhejiang Biomet Medical Products Co. Ltd. | 0 |
| 2017-08-03 | VAI | Voluntary action indicated | Biomet UK Ltd. | 4 |
| 2017-02-10 | NAI | No action indicated | Biomet | 0 |
| 2017-02-03 | NAI | No action indicated | Biomet France SARL | 0 |
| 2016-11-22 | OAI | Official action indicated | Biomet, Inc. | 14 |
| 2016-11-22 | OAI | Official action indicated | Biomet, Inc. | 14 |
| 2016-03-24 | NAI | No action indicated | CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. | 0 |
| 2015-06-03 | WL | Warning Letter | Zhejiang Biomet Medical Products Co. Ltd. | — |
| 2015-03-18 | VAI | Voluntary action indicated | Biomet UK Ltd. | 2 |
| 2015-01-22 | OAI | Official action indicated | Zhejiang Biomet Medical Products Co. Ltd. | 0 |
| 2014-06-30 | VAI | Voluntary action indicated | Biomet, Inc. | 2 |
| 2014-06-30 | VAI | Voluntary action indicated | Biomet, Inc. | 2 |
| 2013-01-18 | NAI | No action indicated | Biomet | 0 |
| 2010-07-27 | WL | Warning Letter | Biomet, Inc. | — |
| 2010-07-27 | WL | Warning Letter | Biomet, Inc. | — |
| 2010-03-26 | NAI | No action indicated | Biomet, Inc. | 0 |
| 2010-03-26 | NAI | No action indicated | Biomet, Inc. | 0 |
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