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TI Cann Partl Thd Recon Screw 6.00MM x 95MM recallZ-2283-2009 · Ebi, L.P. · initiated Apr 2, 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

Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.

FDA root cause category: Nonconforming Material/Component

What the company is doing

The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail. Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure. An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items. On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers. Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.

Recall details

Recall number
Z-2283-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 2, 2009
Posted by the FDA
Sep 22, 2009
Recalling firm
Ebi, L.P.
Quantity
44
Product code
HSB
FDA submissions
K072161
Distribution
Worldwide - US -NY, NJ, MI, MD, FL, GA, PR, MN, SD, OK, TX,, LA, CA, PA, OH, NV, HI, ME, NC, KS, UT, CO, TN, WV, VA, and WA. Foreign: Brazil, Colombia, Denmark, Germany, Finland, Greece, Italy, Japan, The Netherlands, Switzerland, Sweden, Portugal, Spain, United Kingdom, Saudi Arabia, and Trinidad.

Product description

TI Cann Partl Thd Recon Screw 6.00MM x 95MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws.

Code information (models, lots, serial numbers)

Item number 14-406095, Lot number 517330

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.

Other products in the same recall event

The FDA groups related products into one recall event (event 51730).

Sources and updates

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