CLASS II Device recall · Reported 28 Aug 2013 · FDA Enforcement Report
00597002009 Articular Surface CR Art Surf 12/Purple 9, Rx, Sterile recalled
Zimmer is recalling 00597002009 Articular Surface CR Art Surf 12/Purple 9, Rx, Sterile, distributed nationwide in the US. The recall was initiated on 7 Jun 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-2018-2013
- FDA event ID
- 65413
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jun 2013
- FDA classified
- 22 Aug 2013
- Reported
- 28 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Hidden Drug Ingredients
- Device type
- Hip & Knee Implants
Timeline
| 7 Jun 2013 | Recall initiated by company | |
| 22 Aug 2013 | Classified by FDA | +76 days |
| 28 Aug 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d
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Product as listed by the FDA
00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597002012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597002014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Sterile; 00597002017 Articular Surface CR ART SURF 12/PURPLE 17, Rx, Sterile; 00597002020 Articular Surface CR ART SURF 12/PURPLE 20, Rx, Sterile; 00597002023 Articular Surface CR ART SURF 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Where it was distributed
Worldwide Distribution-USA (nationwide) and the country of Japan.
Questions about this recall
Is 00597002009 Articular Surface CR Art Surf 12/Purple 9, Rx, Sterile recalled?
Yes. Zimmer recalled 00597002009 Articular Surface CR Art Surf 12/Purple 9, Rx, Sterile on 7 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-2018-2013.
Why was it recalled?
Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d
Which lots are affected?
all codes
Where was it sold?
Worldwide Distribution-USA (nationwide) and the country of Japan.
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 |