# FDA recall Z-0065-2018

> **Encore Medical, Lp** · Class II · device recall initiated 2017-06-26.

## Product

Cobalt MV Bone Cement 40GM, REF 402438, 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.

## Distribution

Nationwide Distribution

## Key facts

- **Recall number:** Z-0065-2018
- **Recalling firm:** Encore Medical, Lp
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2017-06-26
- **Report date:** 2017-11-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0065-2018

## Citation

> AI Analytics. FDA recall Z-0065-2018. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0065-2018. Source: US FDA. Licensed CC0.

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