Recall Z-0887-2011 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Inc.
TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01, Zimmer, Warsaw, IN. The Zimmer Title 2 counter torque assembly tool is a reuseable, non- implantable surgical tool that is provided as part of a the device system for use as a secondary option for compression and distraction of the construct assembly and initial tightening of set screws. The instrument is designed to
| Date | Jan 10, 2011 (initiated Oct 21, 2010) |
| Status | Terminated |
| Reason | There is a chance that the ball plunger could fall out during surgery and fall into the surgical site. There could be a delay in surgery to remove the ball plunger. If the problem was undetected, the ball plunger could remain in the patient causing pain and potentially necessitating subsequent surgery for removal. |
| Root cause | Other |
| Action | Zimmer sent an URGENT MEDICAL DEVICE RECALL LETTER dated October 21, 2010, to all affected customers. The letter identified the product, the problem, the action to be taken by the customer. Customers were instructed to: Inspect their inventory, stop using the device, and place it in quarantine. Contact Zimmer Customer Service at 1-800-774-6368 to obtain a return authorization number. Complete the Inventory Return Certification form and fax a copy to (952) 837-6958, or scan and email to qualitycompliance@zimmer.com. Return the recalled product along with the original completed Return Cert |
| Quantity | 68 |
| Distribution | Nationwide Distribution including AL, AZ, CA, CO, FL, MI, MN, NC, PA, OH, OK, TN, TX, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.