—#128400

Product

Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K040593
Affected lot / code info: Part Number 00-2358-014-04; lot 62276042

Why it was recalled

A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted in the screw head pulling through plate hole.

Root cause (FDA determination)

Device Design

Action the firm took

Zimmer sent an Urgent Medical Device Recall letter dated June 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. They instructed their distributors to do the following: 1. Please locate, quarantine, and return the affected product (part number 00-2358-014-04; lot 62276042) from all inventories. 2. Please note that any hospitals that received direct shipments of this product from Zimmer will be sent a copy of the Risk Manager and Surgeon letter directly. Additionally, Risk Managers and Surgeon that were identified via invoice data will also receive a letter directly. 3. Please review the list of hospital and surgeons to be provided to your territory via email. 4. Provide the name, address, and phone number of any additional hospitals or surgeons that may have received or used the affected product, or confirm that the list provided is complete. 5. Complete and return Attachment 1. 6. Ensure that a copy of the Risk Managers and Surgeons letter is left with the facilities from which product is removed by providing them with a copy of the letter, if they are not identified as a facility receiving a letter directly from Zimmer. 7.If after reviewing this notification you have questions or concerns, please call 1-877-946-2761. They instructed the Surgeons and Risk Managers to do the following: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Inspect inventory for part number 00-2358-014-04; lot number 62276042. Quarantine the device and contact your Zimmer sales representative to remove and return the affected device. 3. If after reviewing this notification you have questions concerning this notification, please call 1-877-946-2761.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US including the states of CA and OH., and the countries of BRAZIL, CHINA, KOREA and TAIWAN.

Timeline

Recall initiated: 2014-06-10
Posted by FDA: 2014-07-30
Terminated: 2015-01-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128400. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.