Equinoxe® 322-40-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862593887), received between Nov 5, 2024 and Mar 6, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

1 other recall cover devices cleared under the same FDA submission (K223833); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Unstable; Unstable

  IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED IN (B)(6) 2024, UNDERWENT A REVISION PROCEDURE. DATE UNKNOWN. THE SURGEON REVISED THE PATIENT¿S REVERSE SHOULDER DUE TO INSTABILITY. HE REMOVED A 40+0 LINER AND REPLACED IT WITH A 40+2.5 CONSTRAINED LINER. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE UNABLE TO BE OBTAINED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN AS THE HOSPITAL KEPT THE DEVICE. NO DEVICE IMAGES WERE OBTAINED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 21539622 ↗
• InjuryNov 5, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED. THE PATIENT DESCRIBED FEELING ROCKING IN THE SHOULDER WITH RANGE OF MOTION. SURGEON REACHED OUT TO REQUEST INSTRUMENTS FOR EXTRACTION AND REVISION OF CURRENT IMPLANT. AXIAL VIEW DEMONSTRATED A MISALIGNED GLENOSHPERE WHICH APPEARED TO BE SITTING OFF THE BASEPLATE. NO GLENOSPHERE LOCKING SCREW WAS VISUALIZED ON X-RAY. CORONAL VIEW APPEARED NORMAL. UPON EXPOSURE OF THE JOINT, THE GLENOSPHERE WAS LOOSE AND THE LOCKING SCREW APPEARED TO BE BROKEN. SURGEON INSPECTED BASEPLATE AND NOTICED SCREW WAS BROKEN INTO THE CENTER HOLE, WHICH IT INSERTS INTO. SURGEON PROCEEDED TO EXTRACT LOCKING CAPS AND SCREWS USING THE HEX DRIVER AND SUCCESSFULLY EXTRACTED WITHOUT SCREWS BREAKING. ONCE SCREWS WHERE TAKEN OUT OF THE PATIENT, ANOTHER SURGEON ASSISTING ON THE CASE, EXTRACTED THE BASEPLATE VIA HOSPITAL INSTRUMENTS. DOCTORS TOOK THE LINER OFF VIA MALLET AND ELEVATOR, THEN REMOVED TORQUE SCREW WITH REMOVAL TOOL TO TAKE THE TRAY OFF. STEM WAS WELL FIXED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: PLEASE ASK HOSPITAL FOR RETURN OF PRODUCTS.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 20612253 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223833. One submission often covers many models, so check the product and lot details in each record.

• Z-2562-2025 · Aug 15, 2025 · Open, Classified
  Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM L