TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01, Zimmer, Warsaw, IN. The Zimmer Title 2 co

FDA device recall Z-0887-2011 · posted 2011-01-10 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

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.

Action taken

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. .

Root cause

Other

Status

Terminated

Product code

LXH

Quantity affected

68

Distribution

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

Date initiated

2010-10-21

Date posted

2011-01-10

Date terminated

2011-10-12

Location

Warsaw, IN