—#100138

Product

ENDO-FUSE(TM) FUSION ROD 7 mm X 50 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005950, LOT 088605355, IMPLANT MATERIAL: Wright Medical Technology, Inc , 5677 Airline Road, Arlington, TN 38002 The ENDO-FUSE(R) Intra-Osseous Fusion Rods are indicated for the reduction and fixation of fractures. They are indicated for the integral fixation of fractures, bony fusions, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051309
Affected lot / code info: Lot Number 088605355, Reference #500005950

Why it was recalled

Two lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm. Not all parts in each lot are affected. The commingled rod sizes might not be detected prior to surgery.

Root cause (FDA determination)

Process control

Action the firm took

The firm, Wright Medical, sent an "URGENT: Medical Device Voluntary Recall" letter dated May 6, 2011 to their customers via FedEx . The letter describes the product, problem, and actions to be taken. The customers were instructed to examine their inventory for the affected products; immediately return any affected product to Wright Technology as soon as possible (contact Customer Service at 800-238-7117 for return instructions and replacement inventory), and immediately complete and return the attached response form via fax to: 901-867-7401. If you have any questions regarding this matter, please contact 800-874-5630.

Recalling firm

Firm: Wright Medical Technology Inc
Address: 5677 Airline Rd, Arlington, Tennessee 38002-9501

Distribution

Distribution pattern: Nationwide distribution: USA including states of: AL, AZ, CA, CO, FL, ID, IN, IL, LA, MI, MN, MO, NC, NE, NH, NY, OH, PA, SC, TN, TX, VA, VT, WA, and WI.

Timeline

Recall initiated: 2011-04-20
Posted by FDA: 2011-06-17
Terminated: 2012-12-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100138. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.