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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65679

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

Open FDA event record

Event summary

Timeline bucket
July 10, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Pemco 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

Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site

Z-1783-2013
Recall number
Z-1783-2013
Initiated
July 10, 2013
Classification
Class II
Status
Terminated
Recalling firm
Pemco Inc
Quantity
87 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion.

Code information

M/N 4100-IMR-6: S/N's: 4829-4839, 4845-4851, 4857-4871, 4874-4884, 4894-4908 & 4916-4923; M/N 4100-IMR-41: S/N's: 4840-4844, 4852-4856, 4888-4893, 4913-4915 & 4926-4927.

Distribution pattern

Worldwide Distribution - USA including AL, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, OK, PA, TN, TX, UT, VA & WA. Internationally to Czech Republic, Italy, Japan, Korea & Singapore.