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 |
|---|---|---|---|---|---|---|
| 2025-08-15 | Z-2561-2025 | Class II | Open, Classified | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI and the countries of Australia, Austria, Brazil, Canada, Colombia, France, United Kingdom, Guatemala, India, Italy, Japan, Korea, Germany, The Netherlands, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Dubai. | 61,334 UNITS | clearance family |
| 2024-03-06 | Z-1416-2024 | Class II | Open, Classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand | 11863 units | clearance family |
| 2024-03-06 | Z-1417-2024 | Class II | Open, Classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand | 826 units | clearance family |
| 2024-03-06 | Z-1418-2024 | Class II | Open, Classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand | 66646 units | clearance family |
| 2024-03-06 | Z-1419-2024 | Class II | Open, Classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand | 7213 units | clearance family |
| 2024-03-06 | Z-1422-2024 | Class II | Open, Classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand | 24303 units | clearance family |
| 2024-03-06 | Z-1423-2024 | Class II | Open, Classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand | 3648 units | clearance family |
| 2024-03-06 | Z-1424-2024 | Class II | Open, Classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand | 1970 units | clearance family |
| 2024-03-06 | Z-1425-2024 | Class II | Open, Classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand | 591 units | clearance family |
| 2023-11-21 | Z-0579-2024 | Class II | Open, Classified | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.Distribution: US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK | N/A | clearance family |
Showing 1–10 of 17
Regulatory clearances
- 510(k)K150458Substantially equivalent (SESE) · 2015-05-14clearance family
- 510(k)K131575Substantially equivalent (SESE) · 2013-07-03clearance family
- 510(k)K110708Substantially equivalent (SESE) · 2011-04-01clearance family
- 510(k)K101909Substantially equivalent (SESE) · 2010-08-02clearance family
- 510(k)K093275Substantially equivalent (SESE) · 2010-05-27clearance family
Predicate lineage
K063569
Cited as predicate by: K150458, K150568, K162325, K162567, K180632, K182536, K191561, K193098, K213546, K220847, K223833, K233482, K260583
K073688
Cited as predicate by: K150568
K102951
Cited as predicate by: K180632
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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