FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty
- Recall number
- Z-0992-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty
- Status
- Terminated
- Initiated
- 2017-06-30
- Posted
- not on file
- Terminated
- 2018-04-13
- Reason
- Product may contain the presence of melted sterile packaging upon opening.
- Root cause
- Packaging process control
- Action
- 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.
- Quantity
- 30
- Distribution
- US in the state of Texas
- Lot, serial or model codes
- part number: 650-1162 lot number: 2016030466
- 510(k) numbers
- ["K131684"]
- PMA numbers
- not on file
- Product code
- LZO
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28