Equinoxe 320-46-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862086754), received between May 31, 2019 and Aug 22, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

11 other recalls cover devices cleared under the same FDA submission (K063569); 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.

Recalls naming this device

1. Mar 6, 2024Open, Classified

   The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

   Z-1425-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Nov 21, 2023Open, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0579-2024 · Root cause: Packaging change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  APPROXIMATELY 4 YEAR(S), 3 MONTH(S) AND 19 DAY(S) POST-OPERATIVE OF A REVISED LEFT TSA, THE PATIENT PRESENTED WITH DISASSOCIATION OF POLYETHYLENE. PATIENT DESCRIBES INSTABILITY EVENT 2 WEEKS AGO. THE PATIENT UNDERWENT STANDARD REVERSE REVISION SURGERY AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND DEFINITELY NOT RELATED TO THE PROCEDURE. (D10) CONCOMITANT DEVICE(S): 320-01-46 - EQUINOXE REVERSE 46MM GLENOSPHERE: (B)(6), 320-15-05 - EQ REV LOCKING SCREW: (B)(6), 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: (B)(6).

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 20034198 ↗
• InjuryNov 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED APPROXIMATELY 22 MONTHS POSTOP THE INITIAL LTSA THIS (B)(6) Y/O MALE PATIENT REACHED DOWN TO PULL UP A KICKSTAND ON HIS MOTORCYCLE AND FELT A POP. HE WAS REVISED TO THE FOLLOWING, DOWNSIZING FROM 46MM TO 42MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL NOT RETURN DUE TO FACILITY POLICY.

  Patient problems: Joint Dislocation

  MAUDE report 12770117 ↗
• InjuryMay 31, 2019Device Dislodged or Dislocated

  PATIENT WAS WORKING OUT AND STRETCHING WHEN HE FELT SOMETHING HAPPEN IN HIS SHOULDER. WHEN DOCTOR WENT AND COMPLETED THE SURGERY, HE NOTICED THAT THE HUMERAL LINER HAD BECOME DISASSOCIATED FROM THE HUMERAL ADAPTER TRAY.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8659489 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063569. One submission often covers many models, so check the product and lot details in each record.

• Z-2561-2025 · Aug 15, 2025 · Open, Classified
  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/
• Z-1418-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
• Z-1424-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
• Z-1422-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
• Z-1419-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
• Z-1423-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
• Z-3020-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
• Z-3019-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
• Z-0012-2019 · Aug 21, 2018 · Open, Classified
  Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
• Z-0900-2017 · Oct 25, 2016 · Terminated
  Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
• Z-2117-2012 · Jun 15, 2012 · Terminated
  Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.