| | Class 2 Device Recall DJO SURGICAL |  |
| Date Initiated by Firm | July 18, 2025 |
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| Date Posted | September 10, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2546-2025 |
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| Recall Event ID |
97412 |
| 510(K)Number | K233481 |
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| Product Classification |
Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
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| Product | 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 |
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| Code Information |
Lot Code: Item Number: All Lots
GTIN: 00190446843825
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| FEI Number |
1000116912
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Recalling Firm/
Manufacturer |
Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
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| For Additional Information Contact | Sherri Mellingen
952-9136383 |
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Manufacturer Reason
for Recall | Their is a potential that the reamer may kick or bind up during or immediately prior to use. |
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FDA Determined
Cause 2 | Device Design |
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| 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.
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| Quantity in Commerce | 927 units |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = KWS
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