Stryker Howmedica Osteonics Corp.

FDA Regulatory Profile

Summary

Total Recalls
87 (1 Class I)
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2160-2017Class IIHoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131April 26, 2017
Z-1020-2017Class IIReunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, RevisiDecember 2, 2016
Z-0880-2017Class IIGAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-November 9, 2016
Z-0378-2017Class IILFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular August 29, 2016
Z-0060-2017Class IIStryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, HowmeAugust 18, 2016
Z-2789-2016Class IIStryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 0761332721585August 1, 2016
Z-2396-2016Class IIOrthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which iJuly 1, 2016
Z-2791-2016Class IISupracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong anJune 30, 2016
Z-2792-2016Class IIFemoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailiJune 30, 2016
Z-2377-2016Class IIStryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDCJune 23, 2016
Z-2390-2016Class IIStryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, June 23, 2016
Z-2281-2016Class IIStryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non June 3, 2016
Z-0869-2016Class IIStryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of boneJanuary 21, 2016
Z-0882-2016Class IIStryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabiJanuary 21, 2016
Z-0884-2016Class IIStryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilizatiJanuary 21, 2016
Z-0868-2016Class IIStryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stJanuary 21, 2016
Z-0872-2016Class IIStryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabJanuary 21, 2016
Z-0873-2016Class IIStryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segJanuary 21, 2016
Z-0870-2016Class IIStryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilizaJanuary 21, 2016
Z-0876-2016Class IIStryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabiliJanuary 21, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K061493APEX PINSJuly 7, 2006