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.
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: 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) 320-46
- Manufacturer
- Exactech, Inc.
- Hazard
- vacuum-loss
- sterility-compromise
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
Distributed in 16 states:
- AR
- FL
- GA
- IL
- IN
- KY
- MD
- ME
- MN
- NH
- NV
- NY
- SC
- TN
- TX
- VA
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