Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container systems manufactured and distribu
FDA device recall Z-0833-2014 · posted 2014-01-27 · Terminated
Recall details
- Recalling firm
- Symmetry Medical/SSI
- Reason for recall
- The Quad-Lock Sterilization Container System may not maintain an effective sterile barrier.
- Action taken
- The firm notified their consignees of the recall by letter and email on 12/02/2013 instructing customers not to use the containers until further notice from Symmetry Surgical.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KCT
- Quantity affected
- 2,991 units
- Distribution
- Worldwide Distribution - US (Nationwide) and PR; and Internationally to: Italy, Australia, Saudi Arabia, UK, China, Canada, Germany, New Zealand, Colombia, Korea, and Chile.
- Date initiated
- 2013-12-05
- Date posted
- 2014-01-27
- Date terminated
- 2015-04-13
- Location
- Antioch, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM (K120117) | Codman & Shurtleff, Inc. | 2012-04-16 |