FDA Medical Device Recalls (openFDA)
Zimmer Manufacturing B.V.: Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component to perform knee arthroplasty.
- Recall number
- Z-0449-2016
- Recalling firm
- Zimmer Manufacturing B.V.
- Product
- Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component to perform knee arthroplasty.
- Status
- Terminated
- Initiated
- 2015-12-02
- Posted
- not on file
- Terminated
- 2016-09-16
- Reason
- Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264
- Root cause
- Packaging
- Action
- An Urgent Medical Device Recall Letter, dated 12/2/15, was sent to the firm's consignees. All distributors will be notified via electronic mail. Hospital risk managers, surgeons, and distributors with product will be notified via courier.
- Quantity
- 179
- Distribution
- US Distribution and the country of Thailand.
- Lot, serial or model codes
- lot #62460264
- 510(k) numbers
- ["K933785"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1000132037
- Firm city
- Mercedita
- Firm state
- not on file
- Firm country
- PR
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