CLASS II ONGOING Device recall · Reported 17 Sep 2025 · FDA Enforcement Report
Djo Surgical Altivate Reverse Wedge Glenoid Reamer Head recalled
Encore Medical is recalling Djo Surgical Altivate Reverse Wedge Glenoid Reamer Head, 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-2546-2025
- 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
- Sterility
- 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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
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
Is Djo Surgical Altivate Reverse Wedge Glenoid Reamer Head recalled?
Yes. Encore Medical recalled Djo Surgical Altivate Reverse Wedge Glenoid Reamer Head on 18 Jul 2025. The recall is Class II and its status is Ongoing. Recall number Z-2546-2025.
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: Item Number: All Lots GTIN: 00190446843825
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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