Encore Medical, Lp: Medical Device Recall in 2017 - (Recall #: Z-0064-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: June 26, 2017

Date Posted: November 15, 2017

Recall Number: Z-0064-2018

Event ID: 77801

Reason for Recall:

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

Status: Ongoing

Product Quantity: 7143 units

Code Information:

Lot Numbers: 508220, 189680, 199200, 310390, 424730, 668130, 668150, 871240, 959720

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated