Zimmer Recalls Cemented Tibial Drills Due to Bone Perforation Reports
Zimmer, Inc. is recalling 60 Cemented Tibial Drills for the Persona Personalized Knee System after three reports of tibial cortex perforation during use.
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 recall is classified as FDA Class II and involves reports of significant injury (tibial cortex perforation) during a surgical procedure, meeting the criteria for a Severe rating.
Plain-English summary
Zimmer, Inc. is initiating a Class II recall of 60 units of the Cemented Tibial Drill used in the Zimmer Persona Personalized Knee System. The recall is being conducted due to three reports received by August 29, 2012, indicating that tibial cortex perforation occurred during the preparation of the tibial bone. The investigation confirmed that these perforations happened while using the specific drill involved in the recall.
The affected product is identified by Part 42-5399-018-00 and Lots 62034571 and 62089766. The devices were distributed worldwide, including nationwide in the United States and in Australia, the United Arab Emirates, France, Germany, India, and Italy. The cemented tibial drill is a medical instrument used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach, featuring engraved lines to guide insertion depth.
Healthcare providers and facilities that have received these specific lots should stop using the affected drills and contact Zimmer, Inc. for further instructions on the recall process.
The recalled product
- Product
- Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engraved lines that are size specific to guide the user as to the depth to insert th
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 60
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)
- Part 42-5399-018-00
- Lots 62034571
- 62089766
Distribution
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