Exact FDA event identifier

Event 64004

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, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Biomet, 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

TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws, washers, anchors, pins, and suture. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.

Z-0753-2013

Recall number: Z-0753-2013
Initiated: January 03, 2013
Classification: Class II
Status: Terminated
Recalling firm: Biomet, Inc.
Quantity: 44 units distributed

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Thru hole at the tip of the screw is undersized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Reprocessing Controls

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Reason for recall

Thru hole at the tip of the screw is undersized.

Code information

Catalog Number: 909668 Lot Number Identification: 716710

Distribution pattern

Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.