Exactech Equinoxe Shoulder System recalled for vacuum loss in bags
Exactech Equinoxe Reverse Shoulder implants have been recalled due to loss of vacuum in the storage bag. The manufacturer received 3 complaints involving 4 devices.
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: This device is classified as FDA Class II and involves a surgical implant where vacuum integrity in the storage bag is critical for maintaining sterility. While no injuries or hospitalizations have been reported, the loss of vacuum presents a risk to device integrity, fitting the 'risk-of-harm product where injury has not yet been reported' criterion.
Plain-English summary
Exactech, Inc. is recalling its Equinoxe Reverse Shoulder System implants due to loss of vacuum in the innermost vacuum bag. Vacuum integrity in the storage bag is critical to maintaining the sterility and functionality of the surgical implant.
The recall affects devices distributed in the United States (in NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR) and internationally (Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK). Exactech has received 3 complaints involving 4 devices related to this issue.
Patients and healthcare providers should contact Exactech if they have received this implant to determine whether their specific device is affected. Affected devices are identified by specific catalog numbers and serial numbers provided in the recall documentation.
The recalled product
- Product
- Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n)…
- Manufacturer
- Exactech, Inc.
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) 320-36-00
- GTIN 10885862086617
- Serial Numbers: A641190
- A641191
- A641194
- A641202
- A641203
- A641215
- A641221
- A641222
- A641223
- A641224
- A641225
- A641228
- A641229
- A641230
- A641232
- A641233
- A641235
- A641237
Distribution
Part of a larger recall action
This product is one of 12 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 12 products in this recall →Related recalls
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