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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71935

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

Open FDA event record

Event summary

Timeline bucket
August 19, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Med Tec 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

CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.

Z-2763-2015
Recall number
Z-2763-2015
Initiated
August 19, 2015
Classification
Class II
Status
Terminated
Recalling firm
Med Tec Inc
Quantity
18 sets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The wrist straps used for positioning the patient are too long

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The wrist straps used for positioning the patient are too long

Code information

Lot numbers M765570 and M784310.

Distribution pattern

Worldwide Distribution - US including NE, SC, and KS. Foreign distribution was made to Australia, China, Venezuela, Spain, Turkey, and Hong Kong

Field note

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