FDA Medical Device Recalls (openFDA)
Encore Medical, LP: RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
- Recall number
- Z-3021-2020
- Recalling firm
- Encore Medical, LP
- Product
- RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
- Status
- Open, Classified
- Initiated
- 2020-08-07
- Posted
- not on file
- Terminated
- not on file
- Reason
- Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.
- Root cause
- Other
- Action
- Letters were sent to the firm's Field/Sales Agents by email beginning on August 7, 2020. The letters included instructions to take the following actions by August 21, 2020: 1. Pass the notice on to all those within your organization or to any organization where the potentially affected product has been transferred, 2.Contact Customer Service at 1-800-456- 8696 to place a replacement order and receive a Return Materials Authorization (RMA) number, and to be provided with a shipping label to return the affected product. 3. Return all affected devices using the RMA number, and 4. Report any adverse events related to this issue to Customer Service. Customers with questions should contact Christine Chesnutt at 512-834-6207 or christine.chesnutt@djoglobal.com.
- Quantity
- 15 units
- Distribution
- Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA and CA
- Lot, serial or model codes
- Part 509-00-044, Lot 380P1009A , UDI: 00888912144568
- 510(k) numbers
- ["K141006"]
- PMA numbers
- not on file
- Product code
- PHX
- Firm FEI
- 1644408
- 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