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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Smith & Nephew, Inc.: The stability data does not support the product labeled with a 10-year shelf life.

Agency Publication Date: May 2, 2017
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Affected Products

Product: RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)

Batch numbers: 431604,442526,448956,463451,469005,473044,477931,481940,488987,493639,494049,494154, 4357136931,4500034104,07MSY0014,08CSY0043,08CSY0050,08CSY0053,08CSY0053B,08JSY0007, 08LSY0012,08MSY0016,10CSY0006,10HSY0006,11DSY0003,11ESY0007,11FSY0008,11GSY0009, 11GSY0025,11JSY0010,11MSY0020,12ASY0012,12BSY0017,12CSY0006,12HSY0008,12HSY0038, 12KSY0029,12LSY0024,12MSY0024,13BSY0030,13BSY0031,13FSY0018,13FSY0020,13LSY0010, 13MSY0004,14ASY0002,14CSY0007,14CSY0036,14GSY0026,14LSY0011,15ASY0015,15DSY0013, 15FSY0015,15KSY0037,16ASY0007,16BSY0014,16GSY0022,463451A,469005B

Lot Numbers:
numbers
Product: RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)

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

Lot Numbers:
numbers
Product: RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)

Batch numbers: 431604,431612,431614,448956,469005,472361,472767,483297,483890,488786,496187,4500029102, 07LSY0037,07LSY0042,08ESY0005,08ESY0005A,08ESY0007,08ESY0008,08JSY0009,08JSY0009A, 08LSY0050,09BSY0019,09FSY0003,10CSY0007,10ESY0013,11GSY0006,11HSY0009,11KSY0003, 11KSY0069,11MSY0021,12FSY0002,12FSY0029,12GSY0007,12HSY0025,12HSY0040,12KSY0024, 12LSY0021,12MSY0005,12MSY0013,12MSY0025,13BSY0009,13BSY0016,13FSY0022,13JSY0022, 13KSY0048,13MSY0006,14CSY0006,14CSY0038,14HSY0006,15ASY0009,15ASY0018,15ASY0022, 15FSY0016,15JSY0006,15KSY0023,15KSY0039,15MSY0005,16ESY0059,16ESY0075,488369A

Lot Numbers:
numbers
Product: RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)

Batch numbers: 431604,431612,431614,448956,477931,484324,485498,488987,495483,450002910,4500029102, 4500031658,08CSY0044,08ESY0009,08ESY0010,08ESY0011,08JSY0034,08LSY0010,10CSY0008, 10ESY0014,11KSY0004,11KSY0024,12BSY0006,12BSY0014,12DSY0020,12HSY0009,12HSY0041, 12MSY0026,13BSY0032,13FSY0012,13FSY0023,13HSY0008,14BSY0015,14CSY0039,14GSY0025, 14KSY0003,15DSY0002,15FSY0020,15MSY0006,16BSY0010,477931B

Lot Numbers:
numbers
Product: RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)

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

Lot Numbers:
numbers
Product: RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)

Batch numbers: 472439,472579,472580,477931,482918,493639,11150707,4357136921,4500027315,4500030673, 4500032565,07AM06944,07LSY0047,07LSY0048,08BSY0012,08BSY0014B,08BSY0016, 08FSY0051,08JSY0012,08JSY0033,08KSY0015,08KSY0018,08LSY0011,08LSY0044,08LSY0044A, 08MSY0018,09BSY0011,09BSY0025,09DSY0012,09DSY0014,09FSY0005,09HSY0002,09HSY0006, 09HSY0006A,09JSY0002,09JSY0005,09JSY0006,09JSY0007,09JSY0008,09JSY0009,09KSY0002, 10CSY0003,10CSY0013,10CSY0014,10ESY0012,10ESY0017,10GSY0006,10HSY0007,10MSY0007, 11ASY0004,11ASY0008,11CSY0014,11DSY0002,11DSY0012,11ESY0006,11FSY0003,11FSY0004, 11GSY0002,11GSY0019,11GSY0020,11HSY0016,11HSY0023,12CSY0004,12DSY0024,12DSY0027, 12FSY0025,12HSY0006,12HSY0021,12HSY0035,12KSY0021,12LSY0017,12MSY0003,12MSY0011, 13BSY0006,13BSY0012,13BSY0038,13BSY0039,13ESY0006,13FSY0016,13HSY0003,13HSY0006, 13HSY0007,13KSY0047,13MSY0002,14ASY0033,14BSY0011,14CSY0004,14CSY0033,14DSY0013, 14DSY0015,14GSY0018,14HSY0005,14HSY0011,14KSY0002,14LSY0009,15ASY0013,15BSY0008, 15CSY0006,15ESY0024,15FSY0018,15FSY0061,15JSY0003,15KSY0036,15MSY0004,16ASY0006, 16BSY0012,16DSY0023,16ESY0078,16FSY0007,16JSY000516KSY0007,472580B

Lot Numbers:
numbers
Product: RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)

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

Lot Numbers:
numbers
Product: RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)

Batch numbers: 07MSY0006,07MSY0011,07MSY0011A,08CSY0037,08CSY0042,08ESY0082,08FSY0037, 08FSY0037B,08FSY0037C,08JSY0008,08LSY0014,09BSY0012,09JSY0010,09JSY0011,09JSY0012, 10CSY0005,10CSY0017,10CSY0018,10KSY0033,11GSY0004,11GSY0024,11JSY0009,11KSY0068, 11MSY0019,12ASY0011,12BSY0013,12DSY0015,12DSY0029,12FSY0006,12FSY0030,12HSY0023, 12HSY0037,12KSY0023,12LSY0019,12MSY0004,12MSY0018,13BSY0007,13BSY0014,13BSY0041, 13FSY0017,13FSY0019,13LSY0009,13LSY0011,13MSY0003,14ASY0001,14BSY0026,14CSY0035, 14GSY0017,14KSY0017,14LSY0012,15BSY0009,15ESY0009,15ESY0038,15FSY0053,15GSY0017, 15JSY0004,16ASY0003,16BSY0013,16ESY0076,431612,431614,433667,4500029102,4500034104, 455856,469005,472439,472439A,477931,483297,483890,491378,491378A,493639,494049,494154

Lot Numbers:
numbers
Product: RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)

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

Lot Numbers:
numbers
Product: RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)

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

Lot Numbers:
numbers
Product: RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R, QTY: (1)

Batch numbers: 431604,431612,456888,467087,469005,477931,483297,483890,485498,490565,492345,493639, 4500027315,4500029102,4500030972,4500034104,07LSY0011,07LSY0035,07LSY0038,07LSY0040, 08GSY0007,08GSY0007A,08GSY0008,08MSY0015,09BSY0029,10CSY0011,10CSY0023, 10ESY0011,11DSY0006,11DSY0011,11ESY0010,11HSY0012,11HSY0061,11JSY0007,12BSY0015, 12DSY0018,12DSY0030,12FSY0003,12GSY0030,12HSY0028,12HSY0044,12LSY0022,12MSY0007, 12MSY0015,13BSY0010,13BSY0013,13BSY0018,13BSY0035,13KSY0015,13MSY0008,14ASY0035, 14CSY0009,14CSY0042,14KSY0033,14LSY0014,15BSY0011,15DSY0004,15ESY0014,15JSY0008, 16ASY0009,16BSY0016,16KSY0002,469005A

Lot Numbers:
numbers
Product: RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)

Batch numbers: 431604,431612,431614,467087,469005,472361,477931,481940,485498,488987,490565,491378, 492345,4500032273,07LSY0034,07LSY0041,07MSY0013,08FSY0052,08LSY0020,08LSY0020A, 08LSY0042,08MSY0020,09BSY0030,11DSY0007,11ESY0011,11FSY0006,11HSY0013, 11HSY0060,11JSY0008,11JSY0019,12KSY0027,12MSY0008,12MSY0016,13BSY0036, 13FSY0026,13KSY0016,14GSY0013,14KSY0005,15ASY0020,15ESY0015,15JSY0009,15MSY0009, 16ESY0079,477931A,477931B,477931C,490565A,492345A

Lot Numbers:
numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 76943
Status: Resolved
Manufacturer: Smith & Nephew, Inc.
Manufactured In: United States
Units Affected: 12 products (1535 units; 1416 units; 1126 units; 1004 units; 6997 units; 8067 units; 4947 units; 2017 units; 3748 units; 4033 units; 1741 units; 742 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.