Z-2101-2013Class II

Zimmer Periarticular Locking Plate System Distal Medial Humeral Locking Plate, Short Right 11 Holes 178 Mm...

Name: Z-2101-2013 Zimmer Periarticular Locking Plate System Distal Medial Humeral Locking Plate, Short Right 11 Holes 178 Mm...
Creator: Zimmer, Inc.
Published: 2013-07-30
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-07-30 / Terminated / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Product Usage: Usage: The... on 2013-07-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2101-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-30
Posted: 2013-08-27
Terminated: 2014-04-15
Recalling firm: Zimmer GmbH
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.
Product code: HRS Plate, Fixation, Bone
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 11 units
Distribution: Internationally Distributed in China only.
Product codes and lots: Item No. 47-2358-107-11; Lots 61803307, 61969598, and 62084127 Item No. 47-2358-107-15; Lot 61825319

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2101-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2101-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27

Product code HRS

K082078Class IIZimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna PlatesZimmer, Inc. / cleared 2008-11-03

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)