CLASS II Device recall · Reported 10 Feb 2016 · FDA Enforcement Report
Biosure Ratchet Driver, Product No recalled by Smith & Nephew, Inc.
Smith & Nephew, Inc., Endoscopy Div is recalling Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic, distributed in 17 states. The recall was initiated on 4 Apr 2013 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-0700-2016
- FDA event ID
- 72908
- Recalling firm
- Smith & Nephew, Inc., Endoscopy Div, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Apr 2013
- FDA classified
- 29 Jan 2016
- Reported
- 10 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 4 Apr 2013 | Recall initiated by company | |
| 29 Jan 2016 | Classified by FDA | +1030 days |
| 10 Feb 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument
Where it was distributed
Worldwide Distribution - US Distribution to the states of : AK, AL, CA, CO, FL, IL, IN, MI, NE, NJ, NY, OH, OK, PA, SC, TN and TX., and to the countries of : Austria, Australia, Canada, Dubai, Great Britain, India, Italy, Korea, Malaysia, Netherlands, Portugal, Sweden, Switzerland, Singapore and South Africa.
AlaskaAlabamaCaliforniaColoradoFloridaIllinoisIndianaMichiganNebraskaNew JerseyNew YorkOhioOklahomaPennsylvaniaSouth CarolinaTennesseeTexas
Questions about this recall
Is Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic recalled?
Yes. Smith & Nephew, Inc., Endoscopy Div recalled Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic on 4 Apr 2013. The recall is Class II and its status is Terminated. Recall number Z-0700-2016.
Why was it recalled?
Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
Which lots are affected?
Lot Numbers: 50410950 and 50407175
Where was it sold?
Worldwide Distribution - US Distribution to the states of : AK, AL, CA, CO, FL, IL, IN, MI, NE, NJ, NY, OH, OK, PA, SC, TN and TX., and to the countries of : Austria, Australia, Canada, Dubai, Great Britain, India, Italy, Korea, Malaysia, Netherlands, Portugal, Sweden, Switzerland, Singapore and South Africa.
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.
More recalls from Smith & Nephew, Inc., Endoscopy Div
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | High Flow Irrigation Extender recalled by Smith & Nephew, Inc. | Smith & Nephew, Inc., Endoscopy Div | Packaging Defects | 15 states |
| Device | CLASS II | Biosure Driver, Product No: 72201887 For delivery recalled | Smith & Nephew, Inc., Endoscopy Div | Device Malfunction | 17 states |
| Device | CLASS II | Smith & Nephew Mosaicplasty DP- Disposable Harvesting recalled | Smith & Nephew, Inc., Endoscopy Div | Sterility | Nationwide |
| Device | CLASS II | Smith & Nephew Mosaicplasty DP- Disposable Harvesting recalled | Smith & Nephew, Inc., Endoscopy Div | Sterility | Nationwide |
| Device | CLASS II | Smith & Nephew Mosaicplasty DP- Disposable Harvesting recalled | Smith & Nephew, Inc., Endoscopy Div | Sterility | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |