Exactech Equinoxe Reverse Shoulder Liners Recalled for Packaging Nonconformance
Exactech recalls 66,646 Equinoxe Reverse Shoulder humeral liners due to nonconforming packaging lacking required oxygen barrier protection. The missing EVOH layer means units do not meet established packaging specification.
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 involving a risk-of-harm medical device (shoulder implant) where packaging nonconformance could affect protective storage conditions and product stability. No injuries or adverse events have been reported, but the risk-of-harm nature of implanted devices combined with the conformance failure justifies High severity.
Plain-English summary
Exactech, Inc. is recalling 66,646 Equinoxe Reverse Shoulder 38mm humeral liners (Item Numbers 320-38-00 and 320-38-03). These implant components are used in shoulder replacement surgery and were distributed nationwide and internationally to 31 countries.
The packaging of these units is nonconforming. The humeral liners were packaged in vacuum bags that do not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). This missing barrier means the units do not meet the established packaging specification and may not maintain the required protective environment during storage and shipment.
Patients who have received these implants or healthcare providers with unused inventory should contact Exactech, Inc. for further guidance. Specific serial numbers of affected units are available through the FDA or the manufacturer.
The recalled product
- Product
- Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Affected units
- 66,646
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 320-38-00
- UDI/DI 10885862086655
- Serial Numbers: 0983038
- 0983044
- 0983058
- 1033005
- 1034649
- 0983051
- 1032990
- 1032983
- 1032992
- 1092744
- 1092666
- 1092747
- 1030253
- 1092653
- 1092748
- 0983081
- 1032991
- 1034629
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
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