AEQUALIS™ FLEX REVIVE™ ARS655101Recalls & reported problems
Tornier, Inc. · Class 2
All models of AEQUALIS FLEX REVIVE (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832069408), received between Apr 19, 2022 and Jun 10, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
2 FDA recall records name this device's identifier, 2 still open.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Jun 12, 2023Open, Classified
A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.
Z-2020-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 12, 2023Open, Classified
A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.
Z-2019-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Break2
- Fracture2
Patient problems
- Failure of Implant2
- Implant Pain1
- Loss of Range of Motion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2022Break; Fracture; Break; Fracture
AN ACCIDENT INVOLVING A PATIENT WHO HAD A TORNIER AEQUALIS REVERSE RIGHT SHOULDER PROSTHESIS IMPLANTED. SPECIFICALLY, THE PATIENT WAS OPERATED ON AGAIN AFTER SUFFERING PAIN AND AFTER RADIOGRAPHIC CONTROL FOR MECHANICAL FRACTURE OF THE HUMERAL PROSTHETIC STEM (BROKEN HUMERAL BODY ON THE TIGHTENING SCREW BETWEEN BODY AND STEM, NO TIGHTENING OF THE ASSEMBLY SCREW CONNECTING SCREW.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 14660656 ↗InjuryApr 19, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE PATIENT REPORTED A POP IN THE ARM WHICH WAS FOLLOWED BY THE INABILITY TO ACTIVELY RAISE HIS ARM. X-RAY PICTURES SHOWED THAT THE ASSEMBLY SCREW SNAPPED AT THE UNION OF THE DISTAL STEM AND PROXIMAL BODY. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS IN SURGERY TO PULL THE DISTAL STEM OUT OF THE HUMERUS, THE PHYSICIAN DID AN OSTEOTOMY TO GET THE STEM REMOVED. THE PHYSICIAN THEN USED THE HRP STEM TO REPLACE OUR REVIVE STEM.
Patient problems: Failure of Implant; Loss of Range of Motion
MAUDE report 14146782 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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