FDA Medical Device Recalls (openFDA)
EBI, L.P.: Uniflex Ti Buttress Thread Screw; TI Screw Buttress Thread Trauma Fixation Systems, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 Intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred.
- Recall number
- Z-2116-2009
- Recalling firm
- EBI, L.P.
- Product
- Uniflex Ti Buttress Thread Screw; TI Screw Buttress Thread Trauma Fixation Systems, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 Intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred.
- Status
- Terminated
- Initiated
- 2009-03-27
- Posted
- 2009-09-21
- Terminated
- 2009-09-23
- Reason
- Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.
- Root cause
- Nonconforming Material/Component
- Action
- Letters to Biomet/EBI reps were sent on March 29, 2009 by US mail to alert them of the product recall and the affected parts that may be in their possession. They were also asked to notify each customer and locate all affected inventory. All letters advised of the recall and the specific lot numbers involved. A letter was sent to the hospital and physician that received affected parts and asked that implanting physicians make any medical decisions.
- Quantity
- 5
- Distribution
- Worldwide Distribution -- USA and Spain.
- Lot, serial or model codes
- Catalog number: 33-345532; Lot number 598990
- 510(k) numbers
- ["K982953"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 2242816
- Firm city
- Parsippany
- Firm state
- NJ
- 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