Zimmer Persona EM Proximal Tube Recalled for Ratchet Latching Failure
Zimmer, Inc. is recalling 156 Persona EM Proximal Tubes because the ratchet teeth may not latch onto the rod.
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, and the hazard involves a mechanical failure of a surgical instrument that could lead to adverse health consequences, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Zimmer, Inc. is recalling 156 units of the Persona EM Proximal Tube, an orthopedic manual surgical instrument used with the Persona Knee Prosthesis. The specific item number is 42-5399-001-00, and the affected lots are 2137111, 62156913, and 62222598.
The recall was initiated due to complaints that the ratchet teeth of the tube are not latching onto the rod. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
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. Healthcare providers should stop using the affected units and contact Zimmer, Inc. for instructions on return or replacement.
The recalled product
- Product
- Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, 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 (4)
- Proximal Tube Item Number 42-5399-001-00
- Lots: 2137111
- 62156913
- 62222598.
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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