CLASS II Device recall · Reported 8 Aug 2012 · FDA Enforcement Report
Equinoxe Fixed Angle Replicator Plate Intended recalled by Exactech
Exactech is recalling Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder, distributed nationwide in the US. The recall was initiated on 15 Jun 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-2116-2012
- FDA event ID
- 62566
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jun 2012
- FDA classified
- 1 Aug 2012
- Reported
- 8 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 15 Jun 2012 | Recall initiated by company | |
| 1 Aug 2012 | Classified by FDA | +47 days |
| 8 Aug 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty.
Where it was distributed
Worldwide Distribution - USA including FL, MO, MA, AL, KY, IN, NC, LA,PA, VA, OH, NY, ME, MI, TX, KS, TN, OK, NJ, WA, CO, GA, CA, MN, IA, OR, and IL and Internationaly to Austria, Luxenbourg, Sweden, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo.
Nationwide AlabamaCaliforniaColoradoFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaineMichiganMinnesotaMissouriNorth CarolinaNew JerseyNew YorkOhio
Questions about this recall
Is Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder recalled?
Yes. Exactech recalled Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder on 15 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-2116-2012.
Why was it recalled?
Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year
Which lots are affected?
Size: 0mm Catalog Number: 300-25-00 Serial Range: 1999574-2381151
Where was it sold?
Worldwide Distribution - USA including FL, MO, MA, AL, KY, IN, NC, LA,PA, VA, OH, NY, ME, MI, TX, KS, TN, OK, NJ, WA, CO, GA, CA, MN, IA, OR, and IL and Internationaly to Austria, Luxenbourg, Sweden, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo.
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
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|---|---|---|---|---|---|
| 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 |
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| Device | CLASS II | Equinoxe Ergo Ergo Augments Pilot Tip Converter recalled by Exactech | Exactech | Device Malfunction | SC |
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Other Hip & Knee Implants recalls
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|---|---|---|---|---|---|
| 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 |