Class II — Zimmer, Inc.
| Recalling firm | ZIMMER, INC. |
|---|---|
| Registered facility | View this company's 10 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. |
| Product | Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components. |
| Quantity | 1487 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore. |
| Initiated | 2014-05-23 |
| Classified | 2014-07-10 |
| Terminated | 2015-03-06 |
| Recall number | Z-2033-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Zimmer, Inc. (Z-2033-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68390/
Alerts for ZIMMER, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.