Exact FDA event identifier

Event 72500

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

Open FDA event record

Event summary

Timeline bucket: October 13, 2015
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Ceterix Orthopedics, 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

NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.

Z-0250-2016

Recall number: Z-0250-2016
Initiated: October 13, 2015
Classification: Class II
Status: Terminated
Recalling firm: Ceterix Orthopedics, Inc.
Quantity: 1364 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.

Code information

Ceterix catalog number CTX-001; Lot numbers: M150016 M150056 M150078 M150105 M150136 M150182 M150185 M150202 M150207 M150225 M150239.

Distribution pattern

Nationwide Distribution