DJO SURGICAL 804-06-312Recalls & reported problems

Encore Medical, L.P. · ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

7 other recalls cover devices cleared under the same FDA submission (K233481); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Jul 18, 2025Class IIOpen, Classified
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Z-2547-2025 · Root cause: Device Design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K233481. One submission often covers many models, so check the product and lot details in each record.

Z-2549-2025 · Jul 18, 2025 · Open, Classified
Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended
Z-2546-2025 · Jul 18, 2025 · Open, Classified
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile
Z-2548-2025 · Jul 18, 2025 · Open, Classified
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile
Z-2011-2025 · May 28, 2025 · Open, Classified
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.
Z-2009-2025 · May 28, 2025 · Open, Classified
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.
Z-2008-2025 · May 28, 2025 · Open, Classified
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.
Z-2010-2025 · May 28, 2025 · Open, Classified
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.

Device details

UDI-DI	`00190446843832`
Brand	DJO SURGICAL
Model	804-06-312
Company	Encore Medical, L.P.
Product code	PHX · shoulder prosthesis, reverse configuration
Class	Class 2
FDA submission	K233481
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 5, 2024

Device type (GMDN): Cannulated surgical drill bit, reusable

A shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.

Other shoulder prosthesis, reverse configuration devices

DJO SURGICAL 508-36-101
Encore Medical, L.P. · shoulder prosthesis, reverse configuration
508 reports
DJO SURGICAL 508-32-101
Encore Medical, L.P. · shoulder prosthesis, reverse configuration
433 reports
DJO SURGICAL 508-32-103
Encore Medical, L.P. · shoulder prosthesis, reverse configuration
421 reports
DJO SURGICAL 509-00-036
Encore Medical, L.P. · shoulder prosthesis, reverse configuration
1 recall259 reports
DJO SURGICAL 508-32-104
Encore Medical, L.P. · shoulder prosthesis, reverse configuration
1 recall203 reports
DJO SURGICAL 509-00-032
Encore Medical, L.P. · shoulder prosthesis, reverse configuration
233 reports
DELTA XTEND 130760000
Depuy (Ireland) · shoulder prosthesis, reverse configuration
223 reports
DJO SURGICAL 508-00-032
Encore Medical, L.P. · shoulder prosthesis, reverse configuration
122 reports

All shoulder prosthesis, reverse configuration devices →

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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page