Zimmer Recalls Distal Medial Humeral Locking Plates Due to Labeling Error
Zimmer is recalling specific lots of Distal Medial Humeral Locking Plates because the Chinese labels incorrectly identify right-sided implants as left-sided.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall for a labeling error (mis-labeling) where no injuries or illnesses have been reported, fitting the criteria for a Moderate severity score.
Plain-English summary
Zimmer, Inc. is initiating a voluntary recall of specific lots of the Distal Medial Humeral Locking Plate, Short. The recall is limited to 11 units distributed internationally in China. The affected products are identified by Item No. 47-2358-107-11 (Lots 61803307, 61969598, and 62084127) and Item No. 47-2358-107-15 (Lot 61825319).
The reason for the recall is incorrect information printed on the Chinese labels. While the original labels correctly indicate that the implants are right-sided, the Chinese labels incorrectly state that the implants are left-sided. This labeling discrepancy could lead to the use of the wrong implant for a specific patient's anatomy.
Healthcare providers and facilities in China should check their inventory for the specific item numbers and lot numbers listed above. If these products are found, they should be removed from use and returned to Zimmer, Inc. according to the company's instructions.
The recalled product
- 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…
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 11
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Item No. 47-2358-107-11
- Lots 61803307
- 61969598
- and 62084127 Item No. 47-2358-107-15
- Lot 61825319
Distribution
Distribution scope not specified by the agency.
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