CLASS II Device recall · Reported 13 Feb 2013 · FDA Enforcement Report
Novation Crown Cup, Neutral Liner, Use with Crown Cup Only recalled
Exactech is recalling Exactech Novation Crown Cup, Neutral Liner, Use with Crown Cup Only, Gxl Uhmwpe, SN, distributed in Florida, Nevada, Tennessee, Virginia, Washington. The recall was initiated on 5 Nov 2012 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-0787-2013
- FDA event ID
- 64028
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Nov 2012
- FDA classified
- 5 Feb 2013
- Reported
- 13 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 5 Nov 2012 | Recall initiated by company | |
| 5 Feb 2013 | Classified by FDA | +92 days |
| 13 Feb 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.
Product as listed by the FDA
Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
Where it was distributed
Distributed in the states of TN, FL, VA, WA and NV.
Questions about this recall
Is Novation Crown Cup, Neutral Liner, Use with Crown Cup Only, Gxl Uhmwpe, SN 0123456 recalled?
Yes. Exactech recalled Novation Crown Cup, Neutral Liner, Use with Crown Cup Only, Gxl Uhmwpe, SN 0123456 on 5 Nov 2012. The recall is Class II and its status is Terminated. Recall number Z-0787-2013.
Why was it recalled?
Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.
Which lots are affected?
Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898.
Where was it sold?
Distributed in the states of TN, FL, VA, WA and NV.
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.
More recalls from Exactech
All 197| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Equinoxe Core Instrument Kit recalled by Exactech | Exactech | Other | 19 states |
| Device | CLASS II | Equinoxe Ergo Ergo Modular Impactor Handle recalled by Exactech | Exactech | Other | 19 states |
| Device | CLASS II | Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech | Exactech | Device Malfunction | SC |
| Device | CLASS II | Equinoxe Ergo Ergo Augments Pilot Tip Converter recalled by Exactech | Exactech | Device Malfunction | SC |
| Device | CLASS II | Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech | Exactech | Device Malfunction | SC |
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 |