FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G
- Recall number
- Z-0328-06
- Recalling firm
- Encore Medical, Lp
- Product
- Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G
- Status
- Terminated
- Initiated
- 2005-10-21
- Posted
- 2005-12-28
- Terminated
- 2008-04-16
- 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.
- Lot, serial or model codes
- Revision G (instrument not tracked by lot number).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28