RecallRadar

FDA Device recall Z-0626-2024

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

On 2024-01-10 the FDA classified a Class II recall of REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 by Encore Medical, citing mislabeling.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0626-2024
ClassificationClass II
Statuscompleted
Initiated2023-10-05
Published2024-01-10
Last updated2026-09-13 11:57 UTC
CompanyEncore Medical
DistributionUS

Product

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

Reason

Mislabeling

Identifiers

code_infoUDI: (01)00888912108560/Lot Number(s): 157N1556

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0626-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.