FDA Medical Device Recalls (openFDA)
Encore Medical, LP: Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
- Recall number
- Z-1460-2026
- Recalling firm
- Encore Medical, LP
- Product
- Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
- Status
- Open, Classified
- Initiated
- 2026-01-15
- Posted
- 2026-02-24
- Terminated
- not on file
- Reason
- Knee and Humeral socket implants contain incorrect labeling.
- Root cause
- Process control
- 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.
- Quantity
- 20 implants
- Distribution
- US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
- Lot, serial or model codes
- Lot Code: Lot: 378P1382 GTIN: 00888912144544
- 510(k) numbers
- ["K051075"]
- PMA numbers
- not on file
- Product code
- PHX
- 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