Z-1916-2017Class II

Renovation, Thin Osteotome Blade, 20 Mm X 3 Inch, Ref 71369220, Sterile R, Qty: (1)

Name: Z-1916-2017 Renovation, Thin Osteotome Blade, 20 Mm X 3 Inch, Ref 71369220, Sterile R, Qty: (1)
Creator: Smith & Nephew, Inc.
Published: 2017-03-30
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2017-03-30 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc. began a recall of RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1) on 2017-03-30. FDA classified it as Class II and gives the reason as "The stability data does not support the product labeled with a 10-year shelf life". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1916-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-30
Posted: 2017-05-02
Terminated: 2019-08-21
Recalling firm: Smith & Nephew, Inc.
Product: Renovation, Thin Osteotome Blade, 20 Mm X 3 Inch, Ref 71369220, Sterile R, Qty: (1)
Product code: KDG Chisel (Osteotome)
Reason for recall: The stability data does not support the product labeled with a 10-year shelf life.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm initiated their recall by email and letter on 03/30/2017. Consignees were asked to inspect inventory to locate and quarantine affected product. All consignees are asked to complete a Response Form provided with the Field Safety Notice, regardless whether they have affected product. Affected inventory is then to be returned back to Smith & Nephew.
Quantity in commerce: 2017 units
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1916-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1909-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-02
Z-1910-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-02
Z-1911-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-02
Z-1912-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-02
Z-1913-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-02
Z-1914-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-02
Z-1915-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-02
Z-1916-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-02
Z-1917-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-02
Z-1918-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-02
Z-1919-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-02
Z-1920-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-02

Product code KDG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)