FDA Medical Device Recalls (openFDA)
EBI, L.P.: Bone Screw 4.5MM X 52MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 070454 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.
- Recall number
- Z-2296-2009
- Recalling firm
- EBI, L.P.
- Product
- Bone Screw 4.5MM X 52MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 070454 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.
- Status
- Terminated
- Initiated
- 2009-04-02
- Posted
- 2009-09-22
- Terminated
- 2009-09-23
- Reason
- Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 4
- 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.
- Lot, serial or model codes
- Item number 27852, Lot number 696110
- 510(k) numbers
- ["K042237"]
- 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
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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