CLASS II Device recall · Reported 10 May 2017 · FDA Enforcement Report
Renovation, Thin Osteotome Blade X recalled by Smith & Nephew
Smith & Nephew is recalling Renovation, Thin Osteotome Blade X, distributed nationwide in the US. The recall was initiated on 30 Mar 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1917-2017
- FDA event ID
- 76943
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Mar 2017
- FDA classified
- 2 May 2017
- Reported
- 10 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 30 Mar 2017 | Recall initiated by company | |
| 2 May 2017 | Classified by FDA | +33 days |
| 10 May 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The stability data does not support the product labeled with a 10-year shelf life.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)
Where it was distributed
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
Questions about this recall
Is Renovation, Thin Osteotome Blade X recalled?
Yes. Smith & Nephew recalled Renovation, Thin Osteotome Blade X on 30 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1917-2017.
Why was it recalled?
The stability data does not support the product labeled with a 10-year shelf life.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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