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.
What this means for you
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 osteotom
- 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.
Related recalls
Same manufacturer · Zimmer, Inc.
See all →- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- ModerateZimmer Shoulder System Reamer Guide recalled for plastic breakage
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
Same hazard · mis labeling
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02