Z-3022-2020Class II

RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440

Name: Z-3022-2020 RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
Creator: Encore Medical, LP
Published: 2020-08-07
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2020-08-07 / Open, Classified / root cause: labeling and UDI

FDA source

Encore Medical, LP began a recall of RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440 on 2020-08-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3022-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-08-07
Posted: 2020-09-25
Recalling firm: Encore Medical, LP
Product: RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: 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 tag: labeling and UDI
FDA 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 [email protected].
Quantity in commerce: 37 units
Distribution: Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA and CA
Product codes and lots: Part 509-00-440, Lot Numbers 387P1042A and 387P1045A, UDI: 00888912144599

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3022-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3021-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-10-07	2020-09-25
Z-3022-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-10-07	2020-09-25

Product code PHX

K141006Class IIRsp Humeral Socket InsertDjo Global / cleared 2014-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)