Recall Z-2299-2009
Ebi, L.P. · initiated April 2, 2009
Product
Bone Screw4.5MM X 95MM Bone Screw Lock, 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.
Codes / lots: Item number 27895, lot number 717050
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-2299-2009
- Initiated
- April 2, 2009
- Posted by FDA
- September 22, 2009
- Terminated
- September 23, 2009
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 2
- 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.
- Recalling firm
- Ebi, L.P., Parsippany, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2277-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 65MM; Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2278-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 70MM; Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2279-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 75MM; Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2280-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 80MM; Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2281-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 85MM; Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2282-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 90MM; Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2283-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 95MM; Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2284-2009 | TI Cannulated Screw 20MM thrd 6.5MM (d) X 85MM (L); Trauma Fixation Systems, Rx Only…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2285-2009 | TI Cannulated Screw 32MM thrd 7.3MM (d) X 95MM (L); Trauma Fixation Systems, Rx Only…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2286-2009 | TI Cannulated Screw 32MM thrd 7.3MM (d) X 100MM (L); Trauma Fixation Systems, Rx Only…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2287-2009 | TI Cannulated Screw 32MM thrd 7.3MM (d) X 120MM (L); Trauma Fixation Systems, Rx Only…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2288-2009 | TI Screw Buttress Thread 5MM (D) x 35MM (L) Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2289-2009 | TI Screw Buttress Thread 6MM (D) x 65MM (L) Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2290-2009 | Bone Screw 5.5MM X 45MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2291-2009 | Bone Screw 5.5MM X 55MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2292-2009 | Bone Screw 5.5MM X 70MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2293-2009 | Bone Screw 4.5MM X 20MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2294-2009 | Bone Screw 4.5MM X 28MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2295-2009 | Bone Screw 4.5MM X 36MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2296-2009 | Bone Screw 4.5MM X 52MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2297-2009 | Bone Screw .5MM X 60MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2298-2009 | Bone Screw 4.5MM X 70MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2300-2009 | Cannulated Screw Ballista Percutaneous Pedicle Screw System. 6/5 x 45MM; Biomet Spine…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2301-2009 | C-Tek Maxan Anterior Cervical Plate System; 4.0MM X 20MM Fixed Screw' Biomet Spine, 100…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2302-2009 | Pediatric Femoral Nail 5.5MM (d) x 28 CM (L) Rx only, Sterile; Biomet, 100 Interpace…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2303-2009 | Pediatric Femoral Nail 5.5MM (d) x 30 CM (L) Rx only, Sterile; Biomet, 100 Interpace…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2304-2009 | Pediatric Femoral Nail 5.5MM (d) x 32 CM (L) Rx only, Sterile; Biomet, 100 Interpace…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2305-2009 | Pediatric Femoral Nail 5.5MM (d) x 36 CM (L) Rx only, Sterile; Biomet, 100 Interpace…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2306-2009 | Fixed Closed Screw, 6.5mm (D) x 40mm (L), Made in USA; Biomet Spine, Parsippany, NJ The…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2307-2009 | Fixed Open Screw (TI); 7.0MM (D) x 30MM (L); Made In USA, Biomet Spine, Parsippany, NJ…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |