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
FDA Recall Z-2546-2025 · Posted 2025-09-10
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Recalling FirmEncore Medical, LP
Recall StatusOpen, Classified
Product CodeKWS
Date Initiated2025-07-18
Product Quantity927 units
Reason for Recall
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Firm Action
On July 29, 2025, Enovis issued a "Urgent Medical Device Recall Notification via Email to affected consignees. On August 4, 2025, Enovis issued an update to the recall notification via E-Mail requesting consignees rework affected trays and returned affected products. Enovis asked consignees to take the following actions:
1. Continue using the wedge reamer assembly while carefully inspecting and following the specific details in the supplied Quality Bulletin.
2. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred.
3. Please see the attached quality Bulletin
4. By 9/13/25, the firm will reach out regarding reworking and returning trays.
5. Acknowledge receipt of notification.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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