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.
What this means for you
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.
- Hazard
- packaging-defect
- oxygen-exposure
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.
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