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Phoenix Cannulated Recon Screw recallZ-2115-2009 · Ebi, L.P. · initiated Mar 27, 2009

Terminated All recalls posted in September 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ebi, L.P. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-2115-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 27, 2009
Posted by the FDA
Sep 21, 2009
Recalling firm
Ebi, L.P.
Quantity
51
Product code
HSB
FDA submissions
K072161
Distribution
Worldwide Distribution -- USA and Spain.

Product description

Phoenix Cannulated Recon Screw; Ti-Cann PARTL THD Recon Screw Trauma Fixation Systems; Rx only Biomet Trauma, 100 Interpace Parkway, Parsippany, NJ 077054 Intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred.

Code information (models, lots, serial numbers)

Catalog number: 14-406110; Lot number 517350

Other devices under the same FDA submission

4 devices cleared under K072161 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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