Encore Medical, LP recalls Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE M…
Reason for recall
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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-SterileGTIN 00190446843818Affected lot00190446843818
What the firm is doing
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.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2548-2025
- FDA 510(k) clearance · K233481The device's official FDA premarket clearance record
- FDA device classification · KWSOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3660The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Encore Medical, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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