Recalls / —
—#161739
Product
DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty
- FDA product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K131684
- Affected lot / code info
- part number: 650-1162 lot number: 2016030466
Why it was recalled
Product may contain the presence of melted sterile packaging upon opening.
Root cause (FDA determination)
Packaging process control
Action the firm took
On June 2, 2017 an URGENT Medical Recall Letter was issued to customers regarding affected product(s). The letter requests customers to review the content and notify affected personnel of the recall. Assist the sales representative in quarantining affected product, which will be removed and returned to recalling firm and then replaced. All customers who may have received product from distributors are to be notified. Questions or concerns can be directed to 1-574-372-4847.
Recalling firm
- Firm
- Zimmer Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- Distribution pattern
- US in the state of Texas
Timeline
- Recall initiated
- 2017-06-30
- Terminated
- 2018-04-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #161739. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.