SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101. Bone void filler.
FDA device recall Z-0460-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Synthes USA
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 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 produc
- Date initiated
- 2011-09-29
- Date posted
- 2012-01-11
- Date terminated
- 2014-12-18
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NORIAN SRS BONE VOID FILLER (K060408) | Synthes (Usa) | 2006-03-21 |