Z-0699-2016Class II

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

Name: Z-0699-2016 Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual...
Creator: Smith & Nephew, Inc., Endoscopy Div.
Published: 2013-04-04
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2013-04-04 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc., Endoscopy Div. began a recall of Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument on 2013-04-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0699-2016
Classification: Class II
Status: Terminated
Initiated: 2013-04-04
Posted: 2016-01-29
Terminated: 2021-03-22
Recalling firm: Smith & Nephew, Inc.
Product: Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
Product code: HWR Driver, Prosthesis
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Smith & Nephew sent an "Urgent-Product Recall 1st. Notification" dated April 3, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please inspect your inventory and locate all devices from the above listed product and lot numbers and quarantine them immediately. For further questions, please call (978) 749-1000.
Quantity in commerce: 157
Distribution: 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.
Product codes and lots: Lot Numbers: 50409038, 50404149, 50399964

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0699-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0699-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-29
Z-0700-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-29

Product code HWR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)