Cayenne Medical Recalls AperFix Femoral Implant Coring Removal Drills
Cayenne Medical Inc. is recalling specific models of the AperFix Femoral Implant Coring Removal Drill due to a trend of premature wear and breakage identified in 2010.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving structural defects or significant injury risks, even if specific hospitalization reports are not detailed in the provided text snippet.
Plain-English summary
Cayenne Medical Inc. is recalling the AperFix Femoral Implant Coring Removal Drill, which is an orthopedic surgical instrument. The recall includes six specific model numbers: CM-7109, CM-7110, CM-7111, CM-7129, CM-7130, and CM-7131. A total of 1,444 units are affected by this action.
The recall was initiated after a review of product complaints in 2010 identified a trend of premature wear and/or breakage in the Coring Removal Drill. The agency has classified this recall as Class II, indicating 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.
The affected products were distributed worldwide, including nationwide in the United States, as well as in Denmark, Finland, Malaysia, the Netherlands, Poland, Switzerland, and Turkey. Healthcare providers and facilities should stop using the affected devices and contact Cayenne Medical Inc. for instructions on return or replacement.
The recalled product
- Product
- AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral R
- Manufacturer
- Cayenne Medical Inc.
- Hazard
- Affected units
- 1,444
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 (20)
- a. Model Number CM-7109
- Lot Codes: 2091004
- 3041001
- 3151117
- 3250806
- 3291018
- 4191101
- 5181012
- 6211011
- 6270801
- 7081012
- 7131004
- 7231005
- 7281004
- 7281019
- 8161104
- 8311131
- 8311133
- 8311134
- 9081004
Distribution
Distributed nationwide across the United States.
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