Recall Z-0064-2018— Encore Medical, Lp

Name: FDA recall Z-0064-2018
Creator: U.S. Food and Drug Administration
Published: 2017-06-26

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, Lp, initiated 2017-06-26. It names one FDA 510(k) clearance: K051496. Product: Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures. Reason: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement..

Recalling firm: Encore Medical, Lp
Classification: Class II
Status: Ongoing
Initiated: 2017-06-26
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K051496 — COBALT BONE CEMENTBiomet, Inc.·cleared 2005-08-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures

Reason for recall

Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.

Data sourced from openFDA. This site is unofficial and independent of the FDA.