FDA Medical Device Recalls (openFDA)
Encore Medical, LP: Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile
- Recall number
- Z-2547-2025
- Recalling firm
- Encore Medical, LP
- Product
- Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile
- Status
- Open, Classified
- Initiated
- 2025-07-18
- Posted
- 2025-09-10
- Terminated
- not on file
- Reason
- Their is a potential that the reamer may kick or bind up during or immediately prior to use.
- Root cause
- Device Design
- 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.
- Quantity
- 907 units
- Distribution
- 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.
- Lot, serial or model codes
- Lot Code: All Lots GTIN: 00190446843832
- 510(k) numbers
- ["K233481"]
- PMA numbers
- not on file
- Product code
- KWS
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28