🔍 RecallPedia

RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, 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: 431612,452406,455856,463451,472439,472579,483890,485498,494049,495483,4357136940, 4500029102,4500029865,4500032273,4500032667,4500064768,07LSY0010,08BSY0013, 08BSY0015,08FSY0032,08FSY0033,08FSY0033A,08JSY0013,08LSY0009,09BSY0015, 09FSY0007,09HSY0004,09HSY0008,09JSY0004,09JSY0004A,10CSY0009,10CSY0009A, 10CSY0019,10CSY0020,10ESY0016,10HSY0005,10KSY0008,11ASY0011,11BSY0006, 11DSY0004,11DSY0014,11DSY0049,11ESY0008,11FSY0010,11GSY0007,11HSY0010, 11JSY0004,11JSY0012,11MSY0022,12ASY0014,12BSY0019,12CSY0001,12CSY0007,12DSY0016, 12ESY0001,12FSY0028,12GSY0008,12HSY0026,12HSY0042,12KSY0025,12MSY0027,13BSY0008, 13BSY0033,13BSY0042,13DSY0008,13FSY0013,13FSY0024,13JSY0024,13KSY0013,13KSY0014, 13KSY0049,13MSY0007,13MSY0028,14BSY0009,14CSY0031,14CSY0040,14GSY0021,14HSY0012, 14KSY0031,14LSY0013,14LSY0015,15ASY0010,15ASY0016,15BSY0012,15CSY0020,15DSY0014, 15ESY0021,15FSY0025,15GSY0018,15JSY0007,15KSY0024,15MSY0010,16ASY0005,16BSY0011, 16ESY0081,472579A
  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 5 INCH, REF 71369408, STERILE R, QTY: (1)

Product Codes/Lot Numbers:

Batch numbers: 431612,452406,455856,463451,472439,472579,483890,485498,494049,495483,4357136940, 4500029102,4500029865,4500032273,4500032667,4500064768,07LSY0010,08BSY0013, 08BSY0015,08FSY0032,08FSY0033,08FSY0033A,08JSY0013,08LSY0009,09BSY0015, 09FSY0007,09HSY0004,09HSY0008,09JSY0004,09JSY0004A,10CSY0009,10CSY0009A, 10CSY0019,10CSY0020,10ESY0016,10HSY0005,10KSY0008,11ASY0011,11BSY0006, 11DSY0004,11DSY0014,11DSY0049,11ESY0008,11FSY0010,11GSY0007,11HSY0010, 11JSY0004,11JSY0012,11MSY0022,12ASY0014,12BSY0019,12CSY0001,12CSY0007,12DSY0016, 12ESY0001,12FSY0028,12GSY0008,12HSY0026,12HSY0042,12KSY0025,12MSY0027,13BSY0008, 13BSY0033,13BSY0042,13DSY0008,13FSY0013,13FSY0024,13JSY0024,13KSY0013,13KSY0014, 13KSY0049,13MSY0007,13MSY0028,14BSY0009,14CSY0031,14CSY0040,14GSY0021,14HSY0012, 14KSY0031,14LSY0013,14LSY0015,15ASY0010,15ASY0016,15BSY0012,15CSY0020,15DSY0014, 15ESY0021,15FSY0025,15GSY0018,15JSY0007,15KSY0024,15MSY0010,16ASY0005,16BSY0011, 16ESY0081,472579A

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1917-2017

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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