—#95895

Product

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 provide equal torque in the opposite direction to the torque that is being applied to the cap screw during tightening.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: L75118

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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 Certification Form to: Zimmer Spine, Inc. Attn: RA Receiving 5301 Riata Park Ct. Austin, Texas 78727 For questions regarding this recall call Zimmer Spine Customer Service at 1-866-774-6368. .

Recalling firm

Firm: Zimmer Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Nationwide Distribution including AL, AZ, CA, CO, FL, MI, MN, NC, PA, OH, OK, TN, TX, WA, and WI.

Timeline

Recall initiated: 2010-10-21
Posted by FDA: 2011-01-10
Terminated: 2011-10-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95895. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.