Shoulder Implant Recall: Equinoxe Ergo
Exactech, Inc. is recalling reverse shoulder humeral liners used with the Equinoxe Ergo system because the articular surface position is outside the dimensional specification in the labeling. The recall covers 61,334 units with worldwide distribution, including many U.S. states. No corrective action is specified in the provided information.
| Brand | Exactech, Inc. |
|---|---|
| Product | Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/ |
| Reason | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. |
| Severity | moderate |
| Units affected | 120 |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI and the countries of Australia, Austria, Brazil, Canada, Colombia, France, United Kingdom, Guatemala, India, Italy, Japan, Korea, Germany, The Netherlands, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Dubai. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Contact your orthopedic surgeon or hospital to determine if you are affected and to review your implant's reference/serial numbers.
- Schedule an evaluation with your surgeon if advised, to decide on monitoring or potential revision.
- Keep all recall documents and implant information and follow your clinician's instructions.
- If you experience pain, instability, or decreased range of motion, seek medical care promptly and consider reporting your experience to the manufacturer and FDA MedWatch.
How to identify the recalled item
| Lot / date codes | All Serial Numbers, REF: 320-38-00/UDI:10885862086655 REF: 320-38-03/UDI: 10885862086662 REF: 320-42-00/UDI: 10885862086693 REF: 320-42-03/UDI: 10885862086709 |
|---|---|
| Lot / date codes | Lot Code: Part Number: 321-09-05 UDI-DI: 10885862557674 Lot Number: All (Please refer to Attachment 1 - Product Information Spreadsheet for details) |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.