CLASS II ONGOING Device recall · Reported 17 Sep 2025 · FDA Enforcement Report
Djo Surgical Altivate Reverse Wedge Glenoid Reamer Sleeve recalled
Encore Medical is recalling Djo Surgical Altivate Reverse Wedge Glenoid Reamer Sleeve, distributed nationwide in the US. The recall was initiated on 18 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2548-2025
- FDA event ID
- 97412
- Recalling firm
- Encore Medical, Austin, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Jul 2025
- FDA classified
- 10 Sep 2025
- Reported
- 17 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 18 Jul 2025 | Recall initiated by company | |
| 10 Sep 2025 | Classified by FDA | +54 days |
| 17 Sep 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IA, IL, IN, KS, KY, LA, MD, ME, NE, NJ, NY, OH, PR, RI, SC, TN, TX, UT, VA, WA, WI.
Nationwide AlabamaArizonaCaliforniaColoradoFloridaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMarylandMaineNebraskaNew JerseyNew YorkOhioPuerto RicoRhode Island
Questions about this recall
Why was it recalled?
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Which lots are affected?
Lot Code: All Lots GTIN: 00190446843818
Where was it sold?
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IA, IL, IN, KS, KY, LA, MD, ME, NE, NJ, NY, OH, PR, RI, SC, TN, TX, UT, VA, WA, WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 97412This product is part of a recall event; the main page for the event is Djo Surgical Altivate Reverse Wedge Glenoid Reamer Boss Drill recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Djo Surgical Altivate Reverse Wedge Glenoid Reamer Boss Drill recalled | Encore Medical | Other | Nationwide | |
| CLASS II | DJO Surgical FA S Altivate Reverse Glenoid Tray recalled | Encore Medical | Foreign Material | Nationwide | |
| CLASS II | Djo Surgical Altivate Reverse Wedge Glenoid Reamer Head recalled | Encore Medical | Other | Nationwide |
More recalls from Encore Medical
All 99| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Packaging Defects | 14 states |
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Packaging Defects | 14 states |
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Labeling Errors | Nationwide |
| Device | CLASS II | Reverse Shoulder Prosthesis recalled by Encore Medical | Encore Medical | Labeling Errors | Nationwide |
| Device | CLASS II | Reverse Shoulder Prosthesis recalled by Encore Medical | Encore Medical | Labeling Errors | Nationwide |
Other Surgical Instruments recalls
All 3,883| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Packaging Defects | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |