Exactech shoulder implant components recalled for nonconforming packaging
Exactech is recalling 805 Equinoxe glenoid implant components due to nonconforming vacuum packaging that lacks required oxygen barrier protection, which could affect sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for medical device with nonconforming packaging that could compromise sterility of a surgical implant. No illnesses or injuries reported, but the defect represents a potential risk to patient safety.
Plain-English summary
Exactech, Inc. is recalling 805 Equinoxe glenoid components used in shoulder arthroplasty. These are posterior augment glenoids available in small, medium, large, and extra-large sizes in left shoulder configuration.
The recalled components have nonconforming packaging. They were packaged in vacuum bags that do not meet the established specification because they lack an additional oxygen barrier layer made of Ethylene Vinyl Alcohol (EVOH). This missing barrier could compromise product sterility.
The affected components were distributed nationwide in the United States and internationally to 28 countries including 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, and Thailand.
The recalled product
- Product
- Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53…
- Manufacturer
- Exactech, Inc.
- Affected units
- 805
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) Item Number 314-02-22
- UDI/DI 10885862175052
- Serial Numbers: 1984576
- 1984575
- 2090821
- 1984570
- 1984581
- 1984569
- 2090824
- 2093611
- 2090832
- 2090825
- 2379003
- 2090861
- 2090820
- 1984577
- 2090843
- 2378999
- 2379029
- 2425682
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 24 products in this recall →Related recalls
Same manufacturer · Exactech, Inc.
See all →- HighExactech Ergo modular impactor handle may be missing its cross-pin
FDA (Devices) · 2026-03-18
- HighExactech Equinoxe core instrument kits may have handles missing cross-pins
FDA (Devices) · 2026-03-18
- ModeratePilot tip converters recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
- ModerateShoulder reamers recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
- ModerateShoulder reamer 46mm recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
Same hazard · packaging defect
See all →- High
- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateExactech Recalls 30 Mislabeled Equinoxe Shoulder Implant Components
FDA (Devices) · 2018-02-07
- ModerateExactech Recalls 30 Equinoxe Shoulder Implants Due to Mislabeling
FDA (Devices) · 2018-02-07
- HighExactech Equinoxe Shoulder System recalled for loss of vacuum
FDA (Devices) · 2023-12-27
- ModerateExactech Recalls Equinoxe 44mm Short Humeral Head Shoulder Implants
FDA (Devices) · 2015-04-29
- HighExactech Equinoxe Shoulder System recalled for vacuum loss in bags
FDA (Devices) · 2023-12-27
- ModerateExactech Equinoxe Cage Glenoid Posterior Augment Recalled for Mislabeling
FDA (Devices) · 2020-11-25