CLASS II ONGOING Device recall · Reported 10 Apr 2024 · FDA Enforcement Report
Equinoxe Glenoid,Posterior Augment, Pegged, 12o, Right recalled
Exactech is recalling Equinoxe Glenoid,Posterior Augment, Pegged, 12o, Right, For Cemented Use Only, Mates, distributed nationwide in the US. The recall was initiated on 6 Mar 2024 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-1409-2024
- FDA event ID
- 94092
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Mar 2024
- FDA classified
- 29 Mar 2024
- Reported
- 10 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 6 Mar 2024 | Recall initiated by company | |
| 29 Mar 2024 | Classified by FDA | +23 days |
| 10 Apr 2024 | 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
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
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
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-33, c) 44, 47, 50, 53 head, Large, Item Number 314-04-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-35; Shoulder Arthroplasty
Where it was distributed
Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
Questions about this recall
Why was it recalled?
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Which lots are affected?
a) Item Number 314-04-32, UDI/DI 10885862199553, Serial Numbers: 2111957, 2161636, 2111956, 2161639, 3755661; b) Item Number 314-04-33, UDI/DI 10885862199560, Serial Numbers: 2112015, 2112016, 2112013, 2112014, 2136760, 2136755, 2424239, 2424237, 2136756, 2424241, 2712715, 3892095, 3892094; c) Item Number 314-04-34, UDI/DI 10885862199577, Serial Numbers: 2111987, 2111986, 2111984, 2138759, 2138757, 2138754, 2138756, 2138755, 2138753, 2425638, 2485901, 2425634, 2138758, 2111985, 2425636, 2425629, 2425627, 2425625; d) Item Number 314-04-35, UDI/DI 10885862199584, Serial Numbers: 2111991, 2430293, 2430292
Where was it sold?
Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
18 other products · FDA event 94092More 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 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 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 |
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| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |
| Device | CLASS II | Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled | Howmedica Osteonics | Other | Nationwide |