—#120470

Product

ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Product Usage: Usage: The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: Comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K082078
Affected lot / code info: Item No. 47-2358-107-11; Lots 61803307, 61969598, and 62084127 Item No. 47-2358-107-15; Lot 61825319

Why it was recalled

Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, Short due to the incorrect information printed on the Chinese label. The original label indicates that implants are RIGHT sided, but the Chinese label indicates that the implants are LEFT sided.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Zimmer sent an Urgent Medical Device Recall Notification letter dated July 30, 2013 to Distributors and Hospitals in China. The letter described the affected product, problem, labeling issue, directions on how to respond if affected product is discovered, and potential health risks associated with the labeling error. An inventory return certification form is included with the recall notification. Questions or concerns are directed to Zimmer Shanhai at 021-2211 5196, Monday to Friday, between the hours of 9 a.m. and 5 p.m.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Internationally Distributed in China only.

Timeline

Recall initiated: 2013-07-30
Posted by FDA: 2013-08-27
Terminated: 2014-04-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120470. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.