Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4
FDA device recall Z-0938-2015 · posted 2015-01-07 · Terminated
Recall details
- Recalling firm
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Reason for recall
- There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Marrow Aspiration Needle.
- Action taken
- 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 Associate Manager, Quality Assurance and Regulatory Compliance at 610-640-1775 x 5299.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 89770
- Distribution
- Worldwide Distribution: US (nationwide) and country of: Canada.
- Date initiated
- 2014-12-04
- Date posted
- 2015-01-07
- Date terminated
- 2015-07-28
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMBIBE NEEDLE (K140414) | Orthovita, Inc. | 2014-04-01 |