🔍 RecallPedia

RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, 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: 07LSY0036,07LSY0039,08CSY0039,08CSY0041,08CSY0052,08CSY0056,08JSY0011,08JSY0014, 08KSY0012,08LSY0006,08LSY0048,08LSY0049,08MSY0019,09BSY0008,09BSY0009,09BSY0010, 09DSY0011,09DSY0013,09FSY0004,09HSY0001,09HSY0005.09JSY0001,10CSY0002 10CSY0012, 10ESY0007,10ESY0008,10ESY0020,10HSY0008,11ASY0005,11ASY0009,11BSY0005,11CSY0013, 11DSY0001,11ESY0005,11FSY0002,11GSY0001,11GSY0018,11GSY0021,11HSY0063,11JSY0002, 12ASY0016,12BSY0011,12CSY0003,12DSY0023,12DSY0026,12FSY0026,12HSY0005,12HSY0022, 12KSY0020,12LSY0016,12MSY0002,13ASY0008,13ASY0009,13BSY0005,13BSY0011,13BSY0037, 13ESY0010,13ESY0011, 13HSY0002,13HSY0005,13KSY0010,13KSY0046,13MSY0001,14BSY0014, 14CSY0003,14CSY0032,14DSY0014,14GSY0019,14HSY0004,14KSY0001,14LSY0008,15ASY0012, 15ASY0021,15CSY0005,15DSY0001,15ESY0012,15FSY0017,15FSY0060,15HSY0005,15JSY0046, 15KSY0035,15MSY0008,16ASY0001,16DSY0021,16ESY0057,16FSY0001,16GSY0021,431612, 448956,4500030972,4500031584,455856,461831,477931,482918,488987,490565,492345
  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, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)

Product Codes/Lot Numbers:

Batch numbers: 07LSY0036,07LSY0039,08CSY0039,08CSY0041,08CSY0052,08CSY0056,08JSY0011,08JSY0014, 08KSY0012,08LSY0006,08LSY0048,08LSY0049,08MSY0019,09BSY0008,09BSY0009,09BSY0010, 09DSY0011,09DSY0013,09FSY0004,09HSY0001,09HSY0005.09JSY0001,10CSY0002 10CSY0012, 10ESY0007,10ESY0008,10ESY0020,10HSY0008,11ASY0005,11ASY0009,11BSY0005,11CSY0013, 11DSY0001,11ESY0005,11FSY0002,11GSY0001,11GSY0018,11GSY0021,11HSY0063,11JSY0002, 12ASY0016,12BSY0011,12CSY0003,12DSY0023,12DSY0026,12FSY0026,12HSY0005,12HSY0022, 12KSY0020,12LSY0016,12MSY0002,13ASY0008,13ASY0009,13BSY0005,13BSY0011,13BSY0037, 13ESY0010,13ESY0011, 13HSY0002,13HSY0005,13KSY0010,13KSY0046,13MSY0001,14BSY0014, 14CSY0003,14CSY0032,14DSY0014,14GSY0019,14HSY0004,14KSY0001,14LSY0008,15ASY0012, 15ASY0021,15CSY0005,15DSY0001,15ESY0012,15FSY0017,15FSY0060,15HSY0005,15JSY0046, 15KSY0035,15MSY0008,16ASY0001,16DSY0021,16ESY0057,16FSY0001,16GSY0021,431612, 448956,4500030972,4500031584,455856,461831,477931,482918,488987,490565,492345

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1913-2017

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 →