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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64646

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

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Event summary

Timeline bucket
March 14, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Synvasive Technology 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

The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.

Z-1127-2013
Recall number
Z-1127-2013
Initiated
March 14, 2013
Classification
Class II
Status
Terminated
Recalling firm
Synvasive Technology Inc
Quantity
100 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

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Inspect official wording and provenance

Reason for recall

Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.

Code information

Biomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629.

Distribution pattern

USA Nationwide Distributor including the state of IN