Recall Z-2240-2016
Biomet, Inc. · initiated June 10, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies
Codes / lots: All Lots. Part Number / Description: 14-451002 130 DEG 2-HOLE LEFT NECK FX 14-451004 130 DEG 4-HOLE LEFT NECK FX 14-451070 7.5MM TELESCOPE LAG SCR 70MM 14-451075 7.5MM TELESCOPE LAG SCR 75MM 14-451080 7.5MM TELESCOPE LAG SCR 80MM 14-451085 7.5MM TELESCOPE LAG SCR 85MM 14-451090 7.5MM TELESCOPE LAG SCR 90MM 14-451095 7.5MM TELESCOPE LAG SCR 95MM 14-451100 7.5MM TELESCOPE LAG SCR 100MM 14-451102 130 DEG 2-HOLE RIGHT NECK FX 14-451104 130 DEG 4-HOLE RIGHT NECK FX 14-451105 7.5MM TELESCOPE LAG SCR 105MM 14-451110 7.5MM TELESCOPE LAG SCR 110MM 14-451115 7.5MM TELESCOPE LAG SCR 115MM 14-451120 7.5MM TELESCOPE LAG SCR 120MM 14-451125 7.5MM TELESCOPE LAG SCR 125MM 14-451130 7.5MM TELESCOPE LAG SCR 130MM 14-451500 ANGLE GUIDE 130 DEG 14-451502 GUIDE WIRE 3.0MM 14-451503 GUIDE PIN DRIVER 3.0MM 14-451504 TARGETING GUIDE 130 DEG LEFT 14-451505 TARGETING GUIDE 130 DEG RIGHT 14-451509 JIG ATTACHMENT DRIVER 3.5MM 14-451510 NON-LOCK GUIDE SLEEVE 7.5MM 14-451511 LOCKING GUIDE SLEEVE 7.5MM 14-451512 ENTRY TROCAR 7.5 MM 14-451513 DRILL BIT 3.0MM 14-451525 GUIDE WIRE DEPTH GAUGE 3.0MM 14-451526 STEP DRILL CANNULATED 7.5MM 14-451527 STEP DRILL NON-CANN 7.5MM 14-451528 TSP HIP FX TAP 7.5MM 14-451529…
Reason for recall
The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur.
FDA-determined cause: Device Design
Action taken
Zimmer Biomet sent an Urgent Medical Device Recall letter dated June 10, 2016, to all affected customers via courier. Distributors and hospitals were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-6725, Monday through Friday, 8 a.m. to 5 p.m.
Details
- Recall number
- Z-2240-2016
- Initiated
- June 10, 2016
- Posted by FDA
- July 19, 2016
- Terminated
- July 20, 2017
- Product code
- JDO – Device, Fixation, Proximal Femoral, Implant
- Quantity
- 5458 units
- Distribution
- Worldwide Distribution - US (Nationwide) Internationally to Australia, The Netherlands, and Japan
- Recalling firm
- Biomet, Inc., Warsaw, IN