Smith & Nephew, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1912-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)

Product Classification:

Class II

Date Initiated: March 30, 2017

Date Posted: May 10, 2017

Recall Number: Z-1912-2017

Event ID: 76943

Reason for Recall:

The stability data does not support the product labeled with a 10-year shelf life.

Status: Terminated

Product Quantity: 1004 units

Code Information:

Batch numbers: 431604,431612,431614,448956,477931,484324,485498,488987,495483,450002910,4500029102, 4500031658,08CSY0044,08ESY0009,08ESY0010,08ESY0011,08JSY0034,08LSY0010,10CSY0008, 10ESY0014,11KSY0004,11KSY0024,12BSY0006,12BSY0014,12DSY0020,12HSY0009,12HSY0041, 12MSY0026,13BSY0032,13FSY0012,13FSY0023,13HSY0008,14BSY0015,14CSY0039,14GSY0025, 14KSY0003,15DSY0002,15FSY0020,15MSY0006,16BSY0010,477931B

Distribution Pattern:

Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

Voluntary or Mandated:

Voluntary: Firm initiated