Recall Z-0460-2012 ยท MQV Filler, Bone Void, Calcium Compound
Synthes USA
SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101. Bone void filler.
| Date | Jan 11, 2012 (initiated Sep 29, 2011) |
| Status | Terminated |
| Reason | A recent shipment carrying Norian SRS was lost by the carrier. Since the product was lost before final product release testing, Synthes is unable to confirm that Part Number SRS-005-FSP- Lot Number N001101 meets final product release requirements. The product contains all final labeling and cannot be visually distinguished from the product that has met final product release requirements. |
| Root cause | Labeling Change Control |
| Action | All Synthes accounts with a history of purchasing the product in the past two years will be notified by letter of the incident. All firm sales consultants will also receive written notification of the incident. |
| Quantity | 131 units |
| Distribution | Synthes USA sent a "NOTICE: MISSING SHIPMENT-NORIAN SRS" letter dated September 29, 2011 to all accounts with a history of purchasing the product in the past two years. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check thei |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060408 | NORIAN SRS BONE VOID FILLER Synthes (Usa), Mar 21, 2006 |