Pediatric Femoral Nail 5.5MM (d) x 32 CM (L) Rx only, Sterile; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054The 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.
FDA Recall Z-2304-2009 · Posted 2009-09-22
Advertisement
Recalling FirmEBI, L.P.
Recall StatusTerminated
Product CodeHSB
Date Initiated2009-04-02
Date Terminated2009-09-23
Product Quantity4
Reason for Recall
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement