FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: 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.
- Recall number
- Z-2101-2013
- Recalling firm
- Zimmer, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2013-07-30
- Posted
- 2013-08-27
- Terminated
- 2014-04-15
- Reason
- 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
- Labeling mix-ups
- Action
- 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.
- Quantity
- 11 units
- Distribution
- Internationally Distributed in China only.
- Lot, serial or model codes
- Item No. 47-2358-107-11; Lots 61803307, 61969598, and 62084127 Item No. 47-2358-107-15; Lot 61825319
- 510(k) numbers
- ["K082078"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28