DRILL BIT MINI QUICK CONNECT 1 — Class II medical device recall Z-0516-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-02-14, distributed in AK, AL, AR, AZ, CA, CO, FL, GA…. A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the
| Recall number | Z-0516-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-06-12 |
| Classified | 2018-02-04 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2018-06-29 |
| Distributed | 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, WV |
| Countries outside the US | AU, CH, CL, EC, NL, PA |
| Quantity | 1,524 units |
| Reason classes | device malfunction |
| Lot numbers | 100016, 100017, 101028, 102325, 102338, 231220202, 45785, 45790, 46151, 47467, 48461, 48477, 48809, 48811 |
| Model numbers | 2312-20-200, 2312-20-202 |
Product
DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
Reason for recall
A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0516-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.