Recall Z-0938-2015 ยท KNW Instrument, Biopsy
Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch 2090-0029 Needle (bullet-tip), 8 gauge x 6 inch 2090-0047 Needle (bullet-tip), 8 gauge x 8 inch 2090-0030 Needle (bullet-tip), Fenestrated, 8 gauge x 6 inch intended for use to aspirate bone marrow or autologous blood.
| Date | Jan 7, 2015 (initiated Dec 4, 2014) |
| Status | Terminated |
| Reason | There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Marrow Aspiration Needle. |
| Root cause | Package design/selection |
| Action | The firm, Stryker, sent an "URGENT PRODUCT RECALL" letter dated December 4, 2014, to end users/customers. The letter identified the product, problem, and actions to be taken. Customers were instructed to complete and return the URGENT MEDICAL DEVICE RECALL NOTIFICATION ACKNOWLEDGMENT FORM within 5 days via fax to 215-253-5020, contact other hospitals in your territory that have the affected products to arrange return of the product, and return the affected product to: Stryker Orthobiologics, 67 Great Valley Parkway, Malvern, PA 19355. If you have any questions, feel free to contact the Assoc |
| Quantity | 89770 |
| Distribution | Worldwide Distribution: US (nationwide) and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140414 | IMBIBE NEEDLE Orthovita, Inc., Apr 1, 2014 |