Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

U2 Acetabular cup, Ti beads porous coated, 44mm U2 Acetabular cup, Ti beads porous coated, 46mm U2 Acetabular cup, Ti beads porous coated, 48mm U2 Acetabular cup, Ti beads porous coated, 50mm U2 Acetabular cup, Ti beads porous coated, 52mm U2 Acetabular cup, Ti beads porous coated, 54mm U2 Acetabular cup, Ti beads porous coated, 56mm U2 Acetabular cup, Ti beads porous coated, 58mm U2 Acetabular cup, Ti beads porous coated, 60mm U2 Acetabular cup, Ti beads porous coated, 62mm U2 Acetabular cup liner assembly, 10hooded,44mm U2 Acetabular cup liner assembly, 10hooded,46mm U2 Acetabular cup liner assembly, 10hooded,48mm U2 Acetabular cup liner assembly, 10hooded,50mm U2 Acetabular cup liner assembly, 10hooded,52mm U2 Acetabular cup liner assembly, 10hooded,54mm U2 Acetabular cup liner assembly, 10hooded,56mm U2 Acetabular cup liner assembly, 10hooded,58mm U2 Acetabular cup liner assembly, 10hooded,60mm U2 Acetabular cup liner assembly, 10hooded,62mm Variety of hip and knee implants and instruments, multiple uses.

FDA Recall Z-1381-2013 · Posted 2013-05-24

Recalling FirmOrthopedic Alliance LLC
Recall StatusTerminated
Product CodeLPH
Date Initiated2013-02-20
Date Terminated2014-03-26
Product Quantity30 units

Reason for Recall

The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

Firm Action

A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.

Root Cause

Labeling design

Distribution Pattern

Nationwide Distribution including the states of CA, MD, TX, NV, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121777U2 ACETABULAR CUP, PLASMA SPRAYUnited Orthopedic Corp. · 2012-07-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑