🔍 RecallPedia

RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, 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: 431612,433667,448956,466339,469005,473044,473406,477931,484324,485498,4500029102, 4500032273,07LSY0028,07MSY0023,07MSY0027,08CSY0051,08CSY0055,08CSY0055A, 08JSY0032,08LSY0052,09BSY0018,09BSY0027,10GSY0007,11ASY0006,11DSY0048,11FSY0009, 11GSY0005,11HSY0008,11JSY0011,11MSY0017,12ASY0013,12BSY0018,12DSY0019,12FSY0005, 12HSY0024,12HSY0039,12LSY0020,13BSY0015,13FSY0015,13FSY0021,13KSY0011,13MSY0005, 14BSY0010,14CSY0008,14FSY0010,15ASY0014,15CSY0007,15FSY0062,15JSY0005,15LSY0069, 16ASY0004,16ESY0060,448956B,488987A,495483A
  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, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)

Product Codes/Lot Numbers:

Batch numbers: 431612,433667,448956,466339,469005,473044,473406,477931,484324,485498,4500029102, 4500032273,07LSY0028,07MSY0023,07MSY0027,08CSY0051,08CSY0055,08CSY0055A, 08JSY0032,08LSY0052,09BSY0018,09BSY0027,10GSY0007,11ASY0006,11DSY0048,11FSY0009, 11GSY0005,11HSY0008,11JSY0011,11MSY0017,12ASY0013,12BSY0018,12DSY0019,12FSY0005, 12HSY0024,12HSY0039,12LSY0020,13BSY0015,13FSY0015,13FSY0021,13KSY0011,13MSY0005, 14BSY0010,14CSY0008,14FSY0010,15ASY0014,15CSY0007,15FSY0062,15JSY0005,15LSY0069, 16ASY0004,16ESY0060,448956B,488987A,495483A

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1910-2017

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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