Zimmer Title 2 Bone Screw Remover Recalled for Weld Failure Risk
Zimmer, Inc. is recalling 14 Title 2 Bone Screw Remover instruments due to a risk that the weld may break during use, potentially delaying surgery.
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: The recall is classified as FDA Class II. The hazard involves a potential delay in surgery (up to 30 minutes) due to a mechanical failure, but no injuries or illnesses have been reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling 14 units of the Title 2 Bone Screw Remover Instrument, Part Number ET1093-01. This non-sterile, prescription-only device is a component of the Endius TITLE 2 Polyaxial Spinal System, which is used for posterior lumbar fusion procedures. The affected devices are identified by Lot L75066 and were distributed nationwide in the United States.
The recall was initiated because the weld on the quick-connect mechanism may break when force is applied to the handle during pedicle screw removal. If the weld breaks, surgeons may need to use an alternate method to remove the screw, which could delay the surgery by up to 30 minutes.
Healthcare facilities and distributors should stop using the affected devices and contact Zimmer, Inc. for instructions on return or replacement. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endius TITLE 2 Polyaxial Spinal System, used for posterior lumbar fusion procedures.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 14
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 (1)
- Lot: L75066
Distribution
Distributed nationwide across the United States.
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