—#98607

Product

NEXGEN COMPLETE KNEE SOLUTION FEMORAL REPLACEMENT JAW FOR USE WITH FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR , NONSTERILE, REF 00-5901-026-40, Zimmer UK, Ltd., Zimmer Warsaw, IN. Intended use: The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

FDA product code: MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K031061
Affected lot / code info: 6154826, 61645115 and 61690174.

Why it was recalled

The firm is initiating a recall due to the potiential for the spring clip to break off during use and fall into the surgical site. The firm has received 24 complaints of the spring breaking, four of which were reported that the patient had to undergo additional x-rays to ensure the fractured clip had not been left in-vivo.

Root cause (FDA determination)

Device Design

Action the firm took

The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL" notice dated March 14, 2011 to its Consignees/customers. The letter described the product, problem, and the actions to be taken. The customers were instructed to stop using the device and quarantine immediately; carry out a physical count of all affected product in their territory and record this data on the Inventory Return Certification Form and fax to (574) 372-4265; ensure they have provided acknowledgement via "email return receipt" upon receiving notification; return the recalled product along with the completed Inventory Return Certification Form and Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580-Note: The instrument must be returned even if the spring clip is not missing from the instrument; and if they distributed these affected lots further, provide a copy of this letter to the those customers when they implement these recall instructions. The letter stated that a new or refurbished instrument with a redesigned spring clip will be provided as replacement for the recalled device. For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc. at 1-800-613-6131.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide)including states of: HI, CA, NY, MI, IN, GA, FL, WI, MN, NJ, IL, VA, TX, NC, PA, MS, WA, OR, OH, KS, TN, NH, AZ, NV, UT and AK and countries of : Australia, Canada, China, Germany, India, Japan, Singapore and Sweden.

Timeline

Recall initiated: 2011-03-14
Posted by FDA: 2011-05-10
Terminated: 2013-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98607. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.