Zimmer Persona EM Distal Rod Recalled for Ratchet Latching Defect
Zimmer, Inc. is recalling 156 Persona EM Distal Rods because the ratchet teeth may not latch onto the rod. The defect could affect the stability of the surgical instrument during use.
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 is classified as FDA Class II, which corresponds to a 'High' severity score under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling 156 units of the Persona EM Distal Rod, an orthopedic manual surgical instrument used with the Persona Knee Prosthesis. The specific item number is 42-5399-002-00, and it is part of the Persona Tibial Resection System. The recall is due to complaints that the ratchet teeth of the tube are not latching onto the rod.
The affected units were distributed in the states of Arizona, California, Idaho, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, and Washington, as well as in Germany. The specific lot numbers involved are 62137112, 62156914, and 62222599.
This recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences. Healthcare providers and facilities should check their inventory for these specific item and lot numbers and stop using the affected instruments. Patients who have already had surgery using these instruments should contact their healthcare provider if they have concerns, though no specific patient instructions are provided in the source text.
The recalled product
- Product
- Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 156
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)
- Distal Rod Item Number 42-5399-002-00 Lots: 62137112
- 62156914
- 62222599.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer, 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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