CLASS II Device recall · Reported 18 Dec 2013 · FDA Enforcement Report
NexGen Complete Knee Solution CR Articular Surface recalled by Zimmer
Zimmer is recalling NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow Height Nonsterile, distributed nationwide in the US. The recall was initiated on 19 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0462-2014
- FDA event ID
- 66809
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Nov 2013
- FDA classified
- 6 Dec 2013
- Reported
- 18 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 19 Nov 2013 | Recall initiated by company | |
| 6 Dec 2013 | Classified by FDA | +17 days |
| 18 Dec 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadvertently utilized during surgery, resulting in a delay. The associated implants would not be available due to the previous recall.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.
Where it was distributed
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Denmark, Ecuador, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Singapore, South Africa, Spain, Switzerland, UAE, and UK.
Questions about this recall
Is NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow Height Nonsterile recalled?
Yes. Zimmer recalled NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow Height Nonsterile on 19 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0462-2014.
Why was it recalled?
This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadvertently utilized during surgery, resulting in a delay. The associated implants would not be available due to the previous recall.
Which lots are affected?
Part Number 00-5971-031-09
Where was it sold?
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Denmark, Ecuador, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Singapore, South Africa, Spain, Switzerland, UAE, and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |