Recall Z-1397-2013
Orthovita, Inc., dBA Stryker Orthobiologics. · initiated November 10, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Codes / lots: Manufacturer Part Number 2110-0502, Lot Number E909008R
Reason for recall
There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
FDA-determined cause: Labeling design
Action taken
Stryker sent an Urgent Medical Device Correction letter dated November 10, 2012 to all affected customers. The letter identified the affected product, problem issue, potential hazards and actions to be taken. Customers were instructed to immediately review this notification and the attached IFU. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to 1-484-323-8803. For questions contact Stryker Orthobiologics.
Details
- Recall number
- Z-1397-2013
- Initiated
- November 10, 2012
- Posted by FDA
- May 24, 2013
- Terminated
- October 29, 2014
- Product code
- OAR – Injector, Vertebroplasty (Does Not Contain Cement)
- Quantity
- 17
- Distribution
- USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
- Recalling firm
- Orthovita, Inc., dBA Stryker Orthobiologics., Malvern, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1387-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | 11/10/2012Terminated |
| Z-1388-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | 11/10/2012Terminated |
| Z-1389-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | 11/10/2012Terminated |
| Z-1390-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | 11/10/2012Terminated |
| Z-1391-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | 11/10/2012Terminated |
| Z-1392-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | 11/10/2012Terminated |
| Z-1393-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | 11/10/2012Terminated |
| Z-1394-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | 11/10/2012Terminated |
| Z-1395-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | 11/10/2012Terminated |
| Z-1396-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | 11/10/2012Terminated |
| Z-1398-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | 11/10/2012Terminated |
| Z-1399-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | 11/10/2012Terminated |