Exact FDA event identifier

Event 66964

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: November 26, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Biomet, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0523-2014

Recall number: Z-0523-2014
Initiated: November 26, 2013
Classification: Class II
Status: Terminated
Recalling firm: Biomet, Inc.
Quantity: 21

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.

Code information

Lot 055450

Distribution pattern

Nationwide Distribution including MI, IA, IL, IN, and TN.