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
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-06-05 | Z-2050-2023 | Class II | Open, Classified | The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.Distribution: Distribution was made to AR, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MN, NH, NV, NY, OH, OK, PA, SC, TN, TX, WI, as well as PR. There was no government/military distribution. Foreign distribution was made to Australia, France, and Japan. | 250 devices | clearance family |
Regulatory clearances
- 510(k)K213546Substantially equivalent (SESE) · 2022-01-06clearance family
Predicate lineage
- K162567
Cited as predicate by: K173372
- K173372
- K213546
Cited as predicate by: K230904, K232521, K233199, K240062, K242373, K252841
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 |
|---|---|---|---|---|
| 2025-12-19 | WL | Warning Letter | Exactech Sarasota, Inc. | — |
| 2025-08-27 | OAI | Official action indicated | Exactech, Inc. | 9 |
| 2025-08-27 | OAI | Official action indicated | Exactech, Inc. | 9 |
| 2025-07-25 | OAI | Official action indicated | Exactech Sarasota, Inc. | 7 |
| 2024-10-09 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
| 2024-10-09 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
| 2024-01-19 | WL | Warning Letter | Exactech, Inc. | — |
| 2024-01-19 | WL | Warning Letter | Exactech, Inc. | — |
| 2023-09-26 | OAI | Official action indicated | Exactech, Inc. | 2 |
| 2023-09-26 | OAI | Official action indicated | Exactech, Inc. | 2 |
| 2021-11-17 | VAI | Voluntary action indicated | Exactech, Inc. | 4 |
| 2021-11-17 | VAI | Voluntary action indicated | Exactech, Inc. | 4 |
| 2020-01-31 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2020-01-31 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2017-03-10 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2017-03-10 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2015-07-16 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2015-07-16 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2014-08-25 | NAI | No action indicated | Exactech Sarasota, Inc. | 0 |
| 2012-12-11 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2012-12-11 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2010-03-25 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
| 2010-03-25 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
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