Exact FDA event identifier

Event 63520

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

Open FDA event record

Event summary

Timeline bucket: September 20, 2012
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Medline Industries 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

Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure.

Z-0532-2013

Recall number: Z-0532-2013
Initiated: September 20, 2012
Classification: Class II
Status: Terminated
Recalling firm: Medline Industries Inc
Quantity: 18 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pack when it should have been in the sterile portion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pack when it should have been in the sterile portion.

Code information

Reorder #CDS983828, lot numbers 12HD0901 and 12IB1848, expiration date 09/30/2013

Distribution pattern

US (nationwide) in the state of West Virginia