Z-0098-2024Class II

REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130

Name: Z-0098-2024 REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Creator: Encore Medical, LP
Published: 2023-08-22
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2023-08-22 / Open, Classified / root cause: packaging

FDA source

Encore Medical, LP began a recall of REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130 on 2023-08-22. FDA classified it as Class II and gives the reason as "Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0098-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-22
Posted: 2023-10-12
Recalling firm: Encore Medical, LP
Product: REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: On 8/22/23, recall notices were emailed to agents and registration holders who were asked to do the following: Contact Customer Service at 1-800-456-8696 to assist with return and replacement. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. Complete and return the acknowledgement and response form. If you have questions, please email [email protected]
Quantity in commerce: 70
Distribution: US: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX
Product codes and lots: UDI-DI: 00888912024570, Lot: 835C2074, EXP: 2029-03-9

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0098-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0098-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-12

Product code PHX

K041066Class IIEncore Reverse Shoulder ProsthesisEncore Medical L.P. / cleared 2005-03-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)