🔍 RecallPedia

RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, 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: 452406,455856,456888,467087,469005,477931,483890,485094,485498,492100,492345,4500028121, 4500029102,4500032565,07MSY0025,08CSY0040,08FSY0036,08JSY0001,08JSY0010,08JSY0010A, 08JSY0031,08JSY0031A,08KSY0009,08LSY0005,08LSY0021,08LSY0022,08MSY0004,09BSY0028, 09HSY0009,10CSY0010,10CSY0021,10CSY0022,10ESY0010,10ESY0018,10KSY0034,11CSY0010, 11DSY0005,11DSY0013,11DSY0050,11ESY0009,11FSY0005,11GSY0008,11GSY0027,11HSY0011, 11HSY0059,11JSY0005,12ASY0015,12BSY0016,12DSY0017,12ESY0002,12FSY0004,12GSY0031, 12HSY0027,12HSY0043,12KSY0026,12MSY0006,12MSY0028,13BSY0017,13BSY0034,13ESY0007, 13FSY0025,13JSY0023,13KSY0012,13LSY0012,14BSY0001,14BSY0025,14CSY0041,14GSY0020, 14HSY0013,14KSY0004,14KSY0032,14LSY0016,15ASY0017,15ASY0019,15ASY0024,15CSY0008, 15DSY0003,15ESY0013,15FSY0021,15HSY0006,15JSY0010,15KSY0038,15MSY0007,16ASY0008, 16BSY0015,16ESY0080,496187A
  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, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)

Product Codes/Lot Numbers:

Batch numbers: 452406,455856,456888,467087,469005,477931,483890,485094,485498,492100,492345,4500028121, 4500029102,4500032565,07MSY0025,08CSY0040,08FSY0036,08JSY0001,08JSY0010,08JSY0010A, 08JSY0031,08JSY0031A,08KSY0009,08LSY0005,08LSY0021,08LSY0022,08MSY0004,09BSY0028, 09HSY0009,10CSY0010,10CSY0021,10CSY0022,10ESY0010,10ESY0018,10KSY0034,11CSY0010, 11DSY0005,11DSY0013,11DSY0050,11ESY0009,11FSY0005,11GSY0008,11GSY0027,11HSY0011, 11HSY0059,11JSY0005,12ASY0015,12BSY0016,12DSY0017,12ESY0002,12FSY0004,12GSY0031, 12HSY0027,12HSY0043,12KSY0026,12MSY0006,12MSY0028,13BSY0017,13BSY0034,13ESY0007, 13FSY0025,13JSY0023,13KSY0012,13LSY0012,14BSY0001,14BSY0025,14CSY0041,14GSY0020, 14HSY0013,14KSY0004,14KSY0032,14LSY0016,15ASY0017,15ASY0019,15ASY0024,15CSY0008, 15DSY0003,15ESY0013,15FSY0021,15HSY0006,15JSY0010,15KSY0038,15MSY0007,16ASY0008, 16BSY0015,16ESY0080,496187A

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1918-2017

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 →