FDA Medical Device Recalls (openFDA)
Encore Medical, LP: RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
- Recall number
- Z-0282-2024
- Recalling firm
- Encore Medical, LP
- Product
- RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
- Status
- Open, Classified
- Initiated
- 2023-09-25
- Posted
- 2023-11-08
- Terminated
- not on file
- Reason
- Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
- Root cause
- Labeling Change Control
- Action
- On 09/25/23, recall notices were emailed to Agents who were asked to do the following: 1) Pass the notice to all those within your organization or to any organization where the potentially affected product has been transferred. 2) Return all affected devices using the RMA number. 3) Complete and return the response form. Questions can be directed to livia.kuruvila@enovis.com
- Quantity
- 20
- Distribution
- US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
- Lot, serial or model codes
- UDI-DI: 00888912144667, Lot: 390P1157
- 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