Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G
FDA device recall Z-0328-06 · posted 2005-12-28 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Detachable T-handles used in hip instrument sets and shoulder instrument sets may fail during shipment or upon initial use because they were incorrectly assembled.
- Action taken
- The firm initiated the recall on 10/21/05 via letter to all consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 141 units.
- Distribution
- Device distributed nationwide to direct accounts in AZ, CA, FL, GA, IA, IL, KS, LA, MA, MD, MI, MO, MT, NM, NH, NJ, OK, OH, PA, SC, SD, TX, UT, VA, and WA. Foreign distribution to Saudi Arabia, Japan
- Date initiated
- 2005-10-21
- Date posted
- 2005-12-28
- Date terminated
- 2008-04-16
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.