Zimmer Biomet Recalls Humeral Stems Due to Incorrect Lot Number Etching
Zimmer Biomet is recalling 12 Humeral Stems because two lots were commingled and etched with incorrect lot numbers, creating a risk of using the wrong implant size.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (implant size mismatch) where the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is conducting a recall for 12 units of the Humeral Stem 55mm (Size 13). These medical devices are intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty. The recall involves two lots that were commingled during the manufacturing process, resulting in the stems being etched with incorrect lot numbers.
The size difference between the two affected stem sizes is 1.1 inches. The source text notes that it is visually recognizable by the user that the box label does not match the contents of the box. The affected products were distributed nationwide in Minnesota, New Jersey, California, Texas, and North Dakota.
Healthcare providers and facilities should check their inventory for the specific product codes (PN: 113617, LN: 552850) and UDI (01) 00880304554184 (17) 271014 (10) 552850. If these devices are found, they should be removed from use and returned to Zimmer Biomet in accordance with the recall instructions.
The recalled product
- Product
- Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 12
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 (3)
- PN: 113617
- LN: 552850
- UDI# - (01) 00880304554184 (17) 271014 (10) 552850
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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