🔍 RecallPedia

RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, 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: 431604,431612,431614,467087,469005,472361,477931,481940,485498,488987,490565,491378, 492345,4500032273,07LSY0034,07LSY0041,07MSY0013,08FSY0052,08LSY0020,08LSY0020A, 08LSY0042,08MSY0020,09BSY0030,11DSY0007,11ESY0011,11FSY0006,11HSY0013, 11HSY0060,11JSY0008,11JSY0019,12KSY0027,12MSY0008,12MSY0016,13BSY0036, 13FSY0026,13KSY0016,14GSY0013,14KSY0005,15ASY0020,15ESY0015,15JSY0009,15MSY0009, 16ESY0079,477931A,477931B,477931C,490565A,492345A
  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, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)

Product Codes/Lot Numbers:

Batch numbers: 431604,431612,431614,467087,469005,472361,477931,481940,485498,488987,490565,491378, 492345,4500032273,07LSY0034,07LSY0041,07MSY0013,08FSY0052,08LSY0020,08LSY0020A, 08LSY0042,08MSY0020,09BSY0030,11DSY0007,11ESY0011,11FSY0006,11HSY0013, 11HSY0060,11JSY0008,11JSY0019,12KSY0027,12MSY0008,12MSY0016,13BSY0036, 13FSY0026,13KSY0016,14GSY0013,14KSY0005,15ASY0020,15ESY0015,15JSY0009,15MSY0009, 16ESY0079,477931A,477931B,477931C,490565A,492345A

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1920-2017

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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