DePuy Mitek Recalls Latarjet EXPERIENCE Sharp Curved Ostetome
DePuy Mitek is recalling 84 units of the Latarjet EXPERIENCE Sharp Curved Ostetome due to reports of the product loosening or coming unscrewed from the handle.
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 (loosening) of a surgical instrument, which poses a risk of harm during a procedure, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 84 units of the Latarjet EXPERIENCE Sharp Curved Ostetome. This medical device is intended to provide orthopedic surgeons with a means of bone fixation and to assist in the management of reconstructive surgeries.
The recall was initiated due to reports that the product may loosen or come unscrewed from the handle. The affected units were distributed nationwide in the United States, specifically in the states of Ohio, Washington, and Colorado. The recall involves specific lot codes: 16D01, 16D02, 16K01, 17A01, 17B01, and 17B02.
Healthcare providers and consumers should stop using the affected devices and contact DePuy Mitek for further instructions on return or replacement.
The recalled product
- Product
- LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries.
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Hazard
- Affected units
- 84
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 (6)
- 16D01
- 16D02
- 16K01
- 17A01
- 17B01
- 17B02
Distribution
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