🔍 RecallPedia

RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)

Class I - Dangerous
🏥 Medical Devices Recalled: March 30, 2017 Smith & Nephew Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Batch numbers: 431604,442526,448956,463451,469005,473044,477931,481940,488987,493639,494049,494154, 4357136931,4500034104,07MSY0014,08CSY0043,08CSY0050,08CSY0053,08CSY0053B,08JSY0007, 08LSY0012,08MSY0016,10CSY0006,10HSY0006,11DSY0003,11ESY0007,11FSY0008,11GSY0009, 11GSY0025,11JSY0010,11MSY0020,12ASY0012,12BSY0017,12CSY0006,12HSY0008,12HSY0038, 12KSY0029,12LSY0024,12MSY0024,13BSY0030,13BSY0031,13FSY0018,13FSY0020,13LSY0010, 13MSY0004,14ASY0002,14CSY0007,14CSY0036,14GSY0026,14LSY0011,15ASY0015,15DSY0013, 15FSY0015,15KSY0037,16ASY0007,16BSY0014,16GSY0022,463451A,469005B
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Smith & Nephew, Inc.
Reason for Recall:
The stability data does not support the product labeled with a 10-year shelf life.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)

Product Codes/Lot Numbers:

Batch numbers: 431604,442526,448956,463451,469005,473044,477931,481940,488987,493639,494049,494154, 4357136931,4500034104,07MSY0014,08CSY0043,08CSY0050,08CSY0053,08CSY0053B,08JSY0007, 08LSY0012,08MSY0016,10CSY0006,10HSY0006,11DSY0003,11ESY0007,11FSY0008,11GSY0009, 11GSY0025,11JSY0010,11MSY0020,12ASY0012,12BSY0017,12CSY0006,12HSY0008,12HSY0038, 12KSY0029,12LSY0024,12MSY0024,13BSY0030,13BSY0031,13FSY0018,13FSY0020,13LSY0010, 13MSY0004,14ASY0002,14CSY0007,14CSY0036,14GSY0026,14LSY0011,15ASY0015,15DSY0013, 15FSY0015,15KSY0037,16ASY0007,16BSY0014,16GSY0022,463451A,469005B

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1909-2017

Related Recalls

META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

Smith & Nephew

Class I - Dangerous

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

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