🔍 RecallPedia

RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, 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: 431604,431612,456888,467087,469005,477931,483297,483890,485498,490565,492345,493639, 4500027315,4500029102,4500030972,4500034104,07LSY0011,07LSY0035,07LSY0038,07LSY0040, 08GSY0007,08GSY0007A,08GSY0008,08MSY0015,09BSY0029,10CSY0011,10CSY0023, 10ESY0011,11DSY0006,11DSY0011,11ESY0010,11HSY0012,11HSY0061,11JSY0007,12BSY0015, 12DSY0018,12DSY0030,12FSY0003,12GSY0030,12HSY0028,12HSY0044,12LSY0022,12MSY0007, 12MSY0015,13BSY0010,13BSY0013,13BSY0018,13BSY0035,13KSY0015,13MSY0008,14ASY0035, 14CSY0009,14CSY0042,14KSY0033,14LSY0014,15BSY0011,15DSY0004,15ESY0014,15JSY0008, 16ASY0009,16BSY0016,16KSY0002,469005A
  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, 12 MM, REF 71369412, STERILE R, QTY: (1)

Product Codes/Lot Numbers:

Batch numbers: 431604,431612,456888,467087,469005,477931,483297,483890,485498,490565,492345,493639, 4500027315,4500029102,4500030972,4500034104,07LSY0011,07LSY0035,07LSY0038,07LSY0040, 08GSY0007,08GSY0007A,08GSY0008,08MSY0015,09BSY0029,10CSY0011,10CSY0023, 10ESY0011,11DSY0006,11DSY0011,11ESY0010,11HSY0012,11HSY0061,11JSY0007,12BSY0015, 12DSY0018,12DSY0030,12FSY0003,12GSY0030,12HSY0028,12HSY0044,12LSY0022,12MSY0007, 12MSY0015,13BSY0010,13BSY0013,13BSY0018,13BSY0035,13KSY0015,13MSY0008,14ASY0035, 14CSY0009,14CSY0042,14KSY0033,14LSY0014,15BSY0011,15DSY0004,15ESY0014,15JSY0008, 16ASY0009,16BSY0016,16KSY0002,469005A

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1919-2017

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.

Mar 18, 2025 Other Medical Devices Nationwide View Details →