🔍 RecallPedia

RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, 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: 431604,431612,431614,448956,469005,472361,472767,483297,483890,488786,496187,4500029102, 07LSY0037,07LSY0042,08ESY0005,08ESY0005A,08ESY0007,08ESY0008,08JSY0009,08JSY0009A, 08LSY0050,09BSY0019,09FSY0003,10CSY0007,10ESY0013,11GSY0006,11HSY0009,11KSY0003, 11KSY0069,11MSY0021,12FSY0002,12FSY0029,12GSY0007,12HSY0025,12HSY0040,12KSY0024, 12LSY0021,12MSY0005,12MSY0013,12MSY0025,13BSY0009,13BSY0016,13FSY0022,13JSY0022, 13KSY0048,13MSY0006,14CSY0006,14CSY0038,14HSY0006,15ASY0009,15ASY0018,15ASY0022, 15FSY0016,15JSY0006,15KSY0023,15KSY0039,15MSY0005,16ESY0059,16ESY0075,488369A
  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 14, REF 71369314, STERILE R, QTY: (1)

Product Codes/Lot Numbers:

Batch numbers: 431604,431612,431614,448956,469005,472361,472767,483297,483890,488786,496187,4500029102, 07LSY0037,07LSY0042,08ESY0005,08ESY0005A,08ESY0007,08ESY0008,08JSY0009,08JSY0009A, 08LSY0050,09BSY0019,09FSY0003,10CSY0007,10ESY0013,11GSY0006,11HSY0009,11KSY0003, 11KSY0069,11MSY0021,12FSY0002,12FSY0029,12GSY0007,12HSY0025,12HSY0040,12KSY0024, 12LSY0021,12MSY0005,12MSY0013,12MSY0025,13BSY0009,13BSY0016,13FSY0022,13JSY0022, 13KSY0048,13MSY0006,14CSY0006,14CSY0038,14HSY0006,15ASY0009,15ASY0018,15ASY0022, 15FSY0016,15JSY0006,15KSY0023,15KSY0039,15MSY0005,16ESY0059,16ESY0075,488369A

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1911-2017

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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