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Recall Observatory FDA recall evidence

Device product

Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, 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

Z-0066-2018

June 26, 2017

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 77801
Status
Ongoing
Classification
Class II
Quantity
1815 units
Official record key
device-enforcement:Z-0066-2018

Official wording

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

Code information: Lot Numbers: 508250, 959680

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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