Zimmer Biomet Recalls 1.0mm Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 1,524 non-sterile 1.0mm drill bits because a raw material anomaly may increase the risk of instrument fracture.
What this means for you
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. The hazard is a risk of instrument fracture, which is a risk-of-harm product issue where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a score of 3.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,524 units of the DRILL BIT MINI QUICK CONNECT 1.0MM (Item Numbers 2312-20-200 and 2312-20-202). The recall involves specific lot numbers for both item numbers, including lots 45785, 46151, 47467, 48461, 48809, 100016, and 102325 for item 2312-20-200, and lots 45790, 48477, 48811, 100017, 101028, and 102338 for item 2312-20-202.
The recall was initiated after a raw material anomaly was discovered in four lots of raw material. This anomaly has the potential to be on or below the surface of the device components, which can increase the risk of instrument fracture during use.
The affected devices were distributed to facilities in 32 U.S. states, including AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WV. The devices were also distributed internationally to Australia, Chile, Costa Rica, Ecuador, the Netherlands, Panama, and Switzerland. Healthcare facilities should stop using the affected drill bits and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,524
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 (10)
- 231220200 Item Number with the following Lot numbers 45785
- 46151
- 47467
- 48461
- 48809
- 100016 & 102325 231220202 Item Number with the following Lot Numbers: 45790
- 48477
- 48811
- 100017
- 101028 & 102338
Distribution
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