Exactech Equinoxe Reverse Shoulder Humeral Liners Recalled for Packaging Defect
Exactech humeral liners used in shoulder replacement are recalled because the vacuum packaging lacks a required oxygen barrier layer (EVOH), violating established packaging specifications.
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 of a surgical implant with a packaging defect that could affect product integrity. No illnesses or injuries have been reported. The hazard is theoretical—oxygen exposure due to missing EVOH barrier could potentially degrade the implant material—meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Exactech, Inc. is recalling 11,863 units of Exactech Equinoxe REVERSE SHOULDER 36mm Humeral Liners (Item Numbers 320-36-00 and 320-36-03) due to packaging non-conformance. The affected liners are surgical implants used in shoulder arthroplasty (shoulder replacement) procedures.
The humeral liners were packaged in vacuum bags that do not meet the established packaging specification. The bags lack a required additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). This deficiency could allow oxygen exposure to the implant material and does not meet product specification requirements.
The recalled devices have been distributed nationwide in the United States and to multiple countries internationally, 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 REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Affected units
- 11,863
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 320-36-00
- UDI/DI 10885862086617
- Serial Numbers: 1954421
- 1954426
- 1954423
- 1954422
- 1954424
- 2084846
- 2102178
- 2095168
- 2085991
- 2142641
- 2200474
- 2200475
- 2142642
- 2223309
- 2276145
- 2399592
- 2418172
- 2418175
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
- HighReverse shoulder liners recalled over articular surface outside dimensional specification
FDA (Devices) · 2025-09-24
- HighShoulder humeral liners recalled over articular surface outside dimensional specification
FDA (Devices) · 2025-09-24
- HighExactech Equinoxe Shoulder System recalled for vacuum loss in bags
FDA (Devices) · 2023-12-27
- 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
- ModerateExactech Recalls Equinoxe Shoulder Arthroplasty Devices Due to Labeling Error
FDA (Devices) · 2012-08-08