CLASS II Device recall · Reported 25 Dec 2013 · FDA Enforcement Report
outer box recalled by Biomet
Biomet is recalling outer box, distributed nationwide in the US. The recall was initiated on 26 Nov 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-0523-2014
- FDA event ID
- 66964
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Nov 2013
- FDA classified
- 17 Dec 2013
- Reported
- 25 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Syringes & Needles
Timeline
| 26 Nov 2013 | Recall initiated by company | |
| 17 Dec 2013 | Classified by FDA | +21 days |
| 25 Dec 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
Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.
Product as listed by the FDA
outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect label: CurvTek 7 MM Medium, Single Pack Quantity -3, REF 906760 To pass the CurvTek needle, place the jaws of the instrument utilized to grasp the needle on the sides of the needle and orient and needle parallel to the long axis of the instrument. Position the needle to follow the path of the tunnel created by the cartridges. This aligns the needle with the radius of the transosseous tunnel. Advance the needle while rotating the instrument away from the entry point. Gently feed the needle through the length of the tunnel.
Where it was distributed
Nationwide Distribution including MI, IA, IL, IN, and TN.
Questions about this recall
Is outer box recalled?
Yes. Biomet recalled outer box on 26 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0523-2014.
Why was it recalled?
Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.
Which lots are affected?
Lot 055450
Where was it sold?
Nationwide Distribution including MI, IA, IL, IN, and TN.
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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