FDA Device recall Z-0449-2016

Label reading in part as: "NexGen System, Complete Knee Solution

• FDA Device
• Class II
• terminated
• Published 2015-12-30

On 2015-12-30 the FDA classified a Class II recall of Label reading in part as: "NexGen System, Complete Knee Solution by Zimmer Manufacturing B V, citing 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.

Read the official FDA Device notice

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.

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

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Other recalls by Zimmer Manufacturing B V

• VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
  FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
• Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini M…
  FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
• Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabul…
  FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
• Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
  FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
• Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116
  FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V

All Zimmer Manufacturing B V recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0449-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.