Recall Z-0328-06 ยท LXH Orthopedic Manual Surgical Instrument
Encore Medical, Lp
Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G
| Date | Dec 28, 2005 (initiated Oct 21, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | The firm initiated the recall on 10/21/05 via letter to all consignees. |
| Quantity | 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 and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.