CLASS II Device recall · Reported 22 Mar 2017 · FDA Enforcement Report
GRT Tack, drill bit and tack appl., 4x, Sterile recalled by Inion
Inion is recalling Inion GRT Tack, drill bit and tack appl., 4x, Sterile, distributed in Florida, North Carolina. The recall was initiated on 1 Mar 2017 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-1478-2017
- FDA event ID
- 76638
- Recalling firm
- Inion, FIN-33520 Tampere, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Mar 2017
- FDA classified
- 16 Mar 2017
- Reported
- 22 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 1 Mar 2017 | Recall initiated by company | |
| 16 Mar 2017 | Classified by FDA | +15 days |
| 22 Mar 2017 | 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
Aluminum pouch seal was noticed to be defective (slightly open).
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
Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.
Where it was distributed
US Distribution to : FL and NC.
Questions about this recall
Is GRT Tack, drill bit and tack appl., 4x, Sterile recalled?
Yes. Inion recalled GRT Tack, drill bit and tack appl., 4x, Sterile on 1 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1478-2017.
Why was it recalled?
Aluminum pouch seal was noticed to be defective (slightly open).
Which lots are affected?
Lot Number 1604006, 1505007, 1503039
Where was it sold?
US Distribution to : FL and NC.
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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