🔍 RecallPedia

RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, 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: 07MSY0001,08CSY0035,08FSY0034,08FSY0035,08FSY0035A,08LSY0013,08MSY0017,09BSY0023, 09BSY0026,09BSY0026A,09DSY0008,09FSY0006,09HSY0003,09HSY0007,09JSY0003,10CSY0004, 10CSY0015,10CSY0016,10DSY0002,10ESY0009,10ESY0015,10ESY0019,11CSY0009,11CSY0015, 11FSY0007,11GSY0003,11GSY0022,11GSY0023,11HSY0062,11JSY0003,11MSY0018,12ASY0010, 12BSY0012,12CSY0005,12DSY0022,12DSY0028,12FSY0027,12HSY0007,12HSY0036,12KSY0016, 12KSY0022,12LSY0018,12LSY0023,12MSY0012,13ASY0007,13BSY0040,13DSY0009,13DSY0017, 13ESY0008,13ESY0009,13HSY0004,14ASY0034,14CSY0005,14CSY0034,14DSY0016,14DSY0018, 14GSY0016,14KSY0030,14LSY0010,14MSY0012,15ASY0023,15DSY0005,15ESY0020,15FSY0019, 15HSY0011,15JSY0045,15KSY0022,15LSY0070,16ASY0002,16BSY0009,16DSY0022,16ESY0058, 16ESY0077,16JSY0006,3000084920,431604,4500025459,4500030972,4500032273,4500032565, 4500034104,452406,456888,472579,483297,485498
  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, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)

Product Codes/Lot Numbers:

Batch numbers: 07MSY0001,08CSY0035,08FSY0034,08FSY0035,08FSY0035A,08LSY0013,08MSY0017,09BSY0023, 09BSY0026,09BSY0026A,09DSY0008,09FSY0006,09HSY0003,09HSY0007,09JSY0003,10CSY0004, 10CSY0015,10CSY0016,10DSY0002,10ESY0009,10ESY0015,10ESY0019,11CSY0009,11CSY0015, 11FSY0007,11GSY0003,11GSY0022,11GSY0023,11HSY0062,11JSY0003,11MSY0018,12ASY0010, 12BSY0012,12CSY0005,12DSY0022,12DSY0028,12FSY0027,12HSY0007,12HSY0036,12KSY0016, 12KSY0022,12LSY0018,12LSY0023,12MSY0012,13ASY0007,13BSY0040,13DSY0009,13DSY0017, 13ESY0008,13ESY0009,13HSY0004,14ASY0034,14CSY0005,14CSY0034,14DSY0016,14DSY0018, 14GSY0016,14KSY0030,14LSY0010,14MSY0012,15ASY0023,15DSY0005,15ESY0020,15FSY0019, 15HSY0011,15JSY0045,15KSY0022,15LSY0070,16ASY0002,16BSY0009,16DSY0022,16ESY0058, 16ESY0077,16JSY0006,3000084920,431604,4500025459,4500030972,4500032273,4500032565, 4500034104,452406,456888,472579,483297,485498

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1915-2017

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 →