Z-0626-2024Class II

REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2

Name: Z-0626-2024 REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
Creator: Encore Medical, LP
Published: 2023-10-05
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2023-10-05 / Completed / root cause: packaging

FDA source

Encore Medical, LP began a recall of REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 on 2023-10-05. FDA classified it as Class II and gives the reason as "Mislabeling". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0626-2024
Classification: Class II
Status: Completed
Initiated: 2023-10-05
Posted: 2024-01-02
Recalling firm: Encore Medical, LP
Product: REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: Mislabeling
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On October 5, 2022, DJO Global (Enovis company) issued a "Urgent Medical Device Recall" Notification via E-Mail. DJO asked consignees to take the following actions: 1. 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. 2. Review your stock for the affected products and lot numbers for the items to be returned. 3. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. You will be provided with a shipping label to return the affected product. 4. Return all affected devices (quantities listed above) using the RMA number. Report any adverse events related to this issue to Customer Service. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in commerce: 2 units
Distribution: US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
Product codes and lots: UDI: (01)00888912108560/Lot Number(s): 157N1556

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0626-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0625-2024	Class II	Completed	Voluntary: Firm initiated	2024-01-10	2024-01-02
Z-0626-2024	Class II	Completed	Voluntary: Firm initiated	2024-01-10	2024-01-02

Product code PHX

K113756Class IIHighly Cross Linked Ve Central Peg Patella Highly Cross Linked Ve Tri-Peg Patella Highly Cross Linked Ve Metal Backed PaEncore Medical L.P. / cleared 2012-03-14

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)