Class 2 Device Recall Universal Spinal System Lamina Hooks

• Date Initiated by Firm: May 31, 2012
• Date Posted: July 20, 2012
• Recall Status: Terminated on August 31, 2015
• Recall Number: Z-2054-2012
• Recall Event ID: 62324
• 510(K)Number: K020517
• Product Classification: Orthosis, spinal pedicle fixation - Product Code MNI
• Product: Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of these indications: degenerative disc disease, spondylolisthesis, trauma, deformities or curvatures, tumor, stenosis and failed previous fusion.
• Code Information: Catalog number 498.321, lot/serial #6876785
• Recalling Firm/ Manufacturer: Synthes (USA) Products LLC; 1301 Goshen Pkwy; West Chester PA 19380-5986
• For Additional Information Contact: Customer Support; 610-719-6500
• Manufacturer Reason for Recall: USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong part number - 498.321 (Lamina Hook, Medium, Left). The Lamina Hooks should be etched with part number 498.320 (Lamina Hook, Medium, right).
• FDA Determined Cause: Employee error
• Action: SYNTHES sent a Medical Device Recall letter dated May 31, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested consignees and sales reps remove recalled product from their inventory, call the firm at 1-800-479-6329 to receive an authorization number and complete the enclosed verification form and return to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, Colorado 80132. If customers do not have any of the affected product they were instructed to complete the Verification Section at the end of the letter by checking the appropirate box indicating that no affected porudct has been located. Return the document to Synthes by fax to 610-251-9005 or Scan/Email: FieldAction@synthes.com. For any questions please call 610-719-5450.
• Quantity in Commerce: 12 units
• Distribution: Nationwide Distribution including GA, PA, SC, TX, and UT and Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MNI