Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
FDA Recall Z-1460-2026 · Posted 2026-02-24
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Recalling FirmEncore Medical, LP
Recall StatusOpen, Classified
Product CodePHX
Date Initiated2026-01-15
Product Quantity20 implants
Reason for Recall
Knee and Humeral socket implants contain incorrect labeling.
Firm Action
On January 16, 2026 Enovis (Encore Medical, L.P.) issued an Urgent: Medical Device Recall Expansion notification via E-Mail. The expansion was conducted to include additional products. The original notice was issued on July 9, 2025 Enovis is asking consignees to take the following actions
1. Review your stock for the products and lot numbers for the items to be returned.
2. Remove any product from stock and quarantine.
3. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred.
4. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through your regional email.
5. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
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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