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Class 2 Device Recall Drill, 15mm stop |
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| Date Initiated by Firm |
April 08, 2019 |
| Create Date |
May 23, 2019 |
| Recall Status1 |
Terminated 3 on May 11, 2020 |
| Recall Number |
Z-1416-2019 |
| Recall Event ID |
82642 |
| Product Classification |
Bit, drill - Product Code HTW
|
| Product |
Drill, 15mm stop, 1x76mm, AO , Item Number 502015115 |
| Code Information |
All items marked with "Normed" are affected |
Recalling Firm/
Manufacturer |
Zimmer GmbH
Sulzerallee 8
Winterthur Switzerland
|
Manufacturer Reason
for Recall |
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
Urgent Medical Device Recall notification letters dated 4/8/19 were sent to customers. |
| Distribution |
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY. |
| Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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