Exactech Shoulder Implants Recalled for Improper Packaging Defect
Exactech Equinoxe glenoid shoulder implants were packaged with non-conforming bags lacking an oxygen barrier layer (EVOH), creating potential risk of material degradation. The Class II recall affects 180 units distributed nationwide and internationally.
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 orthopedic implants with a packaging defect that could lead to material degradation. This is a risk-of-harm product where no adverse events have been reported, fitting the High severity category.
Plain-English summary
Exactech, Inc. is recalling Equinoxe glenoid implants used in shoulder replacement surgery. The recall affects 180 implant units available in four size variants (Small, Medium, Large, Extra Large), distributed nationwide and internationally.
The affected glenoid implants were packaged in vacuum bags that do not meet the established packaging specification. Specifically, the packaging lacks an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). This barrier layer protects the UHMWPE (ultra-high molecular weight polyethylene) material of the implant from oxygen exposure during storage and transport.
Healthcare providers, hospitals, and surgical centers should verify their inventory using the specific serial numbers and item numbers listed for each variant (Item Numbers 314-06-22, 314-06-23, 314-06-24, and 314-06-25). Any affected implants in inventory should not be used. Patients who may have already received an affected implant should consult with their healthcare provider.
The recalled product
- Product
- Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-06-23, c) 44, 47, 50, 53 head, Large, Item Number 314-06-24, d) 44,
- Manufacturer
- Exactech, Inc.
- Hazard
- packaging-defect
- material-degradation
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 314-06-22
- UDI/DI 10885862228307
- Serial Numbers: 2579212
- 2634987
- 2635008
- 2579195
- 2579206
- 2811940
- 2811957
- 2811935
- 2634983
- 5718616
- 5718644
- 5718619
- 5933499
- 5933502
- 5704955
- 6756450
- 6756452
- 5718637
Distribution
Distributed nationwide across the United States.
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