FDA event 76943 · Recall Observatory

device · product 1 of 12

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

Z-1909-2017

Recall number: Z-1909-2017
Initiated: March 30, 2017
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 1535 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The stability data does not support the product labeled with a 10-year shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The stability data does not support the product labeled with a 10-year shelf life.

Code information

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

Distribution pattern

Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

device · product 2 of 12

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

Z-1910-2017

Recall number: Z-1910-2017
Initiated: March 30, 2017
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 1416 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The stability data does not support the product labeled with a 10-year shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The stability data does not support the product labeled with a 10-year shelf life.

Code information

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

Distribution pattern

Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

device · product 3 of 12

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

Z-1911-2017

Recall number: Z-1911-2017
Initiated: March 30, 2017
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 1126 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The stability data does not support the product labeled with a 10-year shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The stability data does not support the product labeled with a 10-year shelf life.

Code information

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

Distribution pattern

Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

device · product 4 of 12

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

Z-1912-2017

Recall number: Z-1912-2017
Initiated: March 30, 2017
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 1004 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The stability data does not support the product labeled with a 10-year shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The stability data does not support the product labeled with a 10-year shelf life.

Code information

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

Distribution pattern

Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

device · product 5 of 12

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

Z-1913-2017

Recall number: Z-1913-2017
Initiated: March 30, 2017
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 6997 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The stability data does not support the product labeled with a 10-year shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The stability data does not support the product labeled with a 10-year shelf life.

Code information

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

Distribution pattern

Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

device · product 6 of 12

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

Z-1914-2017

Recall number: Z-1914-2017
Initiated: March 30, 2017
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 8067 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The stability data does not support the product labeled with a 10-year shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The stability data does not support the product labeled with a 10-year shelf life.

Code information

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

Distribution pattern

Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

device · product 7 of 12

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

Z-1915-2017

Recall number: Z-1915-2017
Initiated: March 30, 2017
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 4947 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The stability data does not support the product labeled with a 10-year shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The stability data does not support the product labeled with a 10-year shelf life.

Code information

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

Distribution pattern

Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

device · product 8 of 12

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

Z-1916-2017

Recall number: Z-1916-2017
Initiated: March 30, 2017
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 2017 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The stability data does not support the product labeled with a 10-year shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The stability data does not support the product labeled with a 10-year shelf life.

Code information

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

Distribution pattern

Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

device · product 9 of 12

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

Z-1917-2017

Recall number: Z-1917-2017
Initiated: March 30, 2017
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 3748 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The stability data does not support the product labeled with a 10-year shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The stability data does not support the product labeled with a 10-year shelf life.

Code information

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

Distribution pattern

Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

device · product 10 of 12

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

Z-1918-2017

Recall number: Z-1918-2017
Initiated: March 30, 2017
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 4033 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The stability data does not support the product labeled with a 10-year shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The stability data does not support the product labeled with a 10-year shelf life.

Code information

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

Distribution pattern

Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

device · product 11 of 12

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

Z-1919-2017

Recall number: Z-1919-2017
Initiated: March 30, 2017
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 1741 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The stability data does not support the product labeled with a 10-year shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The stability data does not support the product labeled with a 10-year shelf life.

Code information

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

Distribution pattern

Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

device · product 12 of 12

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

Z-1920-2017

Recall number: Z-1920-2017
Initiated: March 30, 2017
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 742 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The stability data does not support the product labeled with a 10-year shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The stability data does not support the product labeled with a 10-year shelf life.

Code information

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

Distribution pattern

Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

Event summary

Source snapshots represented here

Every recalled product in this event

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