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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72908

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

Open FDA event record

Event summary

Timeline bucket
April 04, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Smith & Nephew, Inc., Endoscopy Div.

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

Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument

Z-0699-2016
Recall number
Z-0699-2016
Initiated
April 04, 2013
Classification
Class II
Status
Terminated
Quantity
157

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
does not meet specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.

Code information

Lot Numbers: 50409038, 50404149, 50399964

Distribution pattern

Worldwide Distribution - US Distribution to the states of : AK, AL, CA, CO, FL, IL, IN, MI, NE, NJ, NY, OH, OK, PA, SC, TN and TX., and to the countries of : Austria, Australia, Canada, Dubai, Great Britain, India, Italy, Korea, Malaysia, Netherlands, Portugal, Sweden, Switzerland, Singapore and South Africa.

device · product 2 of 2

Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument

Z-0700-2016
Recall number
Z-0700-2016
Initiated
April 04, 2013
Classification
Class II
Status
Terminated
Quantity
9

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
does not meet specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.

Code information

Lot Numbers: 50410950 and 50407175

Distribution pattern

Worldwide Distribution - US Distribution to the states of : AK, AL, CA, CO, FL, IL, IN, MI, NE, NJ, NY, OH, OK, PA, SC, TN and TX., and to the countries of : Austria, Australia, Canada, Dubai, Great Britain, India, Italy, Korea, Malaysia, Netherlands, Portugal, Sweden, Switzerland, Singapore and South Africa.