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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84752

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

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Event summary

Timeline bucket
January 03, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer Surgical 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

Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field.

Z-1356-2020
Recall number
Z-1356-2020
Initiated
January 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Surgical Inc
Quantity
58

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.

Code information

Lot 27968701

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of CA, FL, IA, ID, IL, LA, MA, MO, NC, NY, OH, OR, PA, SC, TN, TX, WA, WI, and WV and country of Netherlands.