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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63744

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 19, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
BioHorizons Implant Systems 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

2 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 2

AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

Z-0561-2013
Recall number
Z-0561-2013
Initiated
November 19, 2012
Classification
Class II
Status
Terminated
Quantity
174 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.

Code information

Lot Numbers: 02070051, 04070030, 0800152, 06070018, 0801863, 0802225, 0802469, 0900838, 0901751, 0902145, 0902956, 1000003, 1001504, 1004620, 1101301, 1101802, 1103359, 1104032, 1104976, 1200616, and 1202282

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Ecuador, Egypt, Fiji, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Panama, Peru, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.

device · product 2 of 2

Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

Z-0562-2013
Recall number
Z-0562-2013
Initiated
November 19, 2012
Classification
Class II
Status
Terminated
Quantity
1246 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.

Code information

Lot Numbers: K0207015, K0307007, K0407011, K0507007, K0507008, K0507010, K0607003, K0607008, K0607009, K0607017, K0707010, K0707014, K0907001, K0907009, K0907011, K1007006, K1007007, K1007008, K1107009, K1107010, K1107012, K1207002, K0208005, K0208005R, K0308003, 0800120, 0800450, 0800451, 0800674, 0801215, 0801256, 0801728, 0801894, 0802232, 0802528, 0803139, 0900023, 0900884, 0901727, 0902402, 0903145, 0903480, 1000059, 1001465, 1002292, 1004118, 1005055, 1100381, 1100806, 1101066, 1101555, 1102699, 1103390, 1103811, 1104079, 1104778, 1105636, 1200829, 1201978, 1202444, and 1203107

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Ecuador, Egypt, Fiji, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Panama, Peru, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.