Z-1465-2019Class II
V-TEK", Micro-countersink, AO, Item Number 28.66.113
Zimmer GmbH / initiated 2019-04-08 / Terminated / root cause: manufacturing process
Zimmer GmbH began a recall of V-TEK", Micro-countersink, AO, Item Number 28.66.113 on . FDA classified it as Class II and gives the reason as "An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1465-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- V-TEK", Micro-countersink, AO, Item Number 28.66.113
- Product code
- HWW Countersink
- Reason for recall
- An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- Root cause tag
- manufacturing process
- FDA root cause
- 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.
- Product codes and lots
- All items marked with "Normed" are affected
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1413-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1414-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1415-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1416-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1417-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1418-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1419-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1420-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1421-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1422-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1423-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1424-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1425-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1426-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1427-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1428-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1429-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1430-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1431-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1432-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1433-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1434-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1435-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1436-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1437-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1438-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1439-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1440-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1441-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1442-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1443-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1444-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1445-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1446-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1447-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1448-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1449-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1450-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1451-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1452-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1453-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1454-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1455-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1456-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1457-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1458-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1459-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1460-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1461-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1462-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1463-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1464-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1465-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1466-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1467-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1468-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1469-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1470-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1471-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1472-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1473-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1474-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1475-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1476-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1477-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1478-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1479-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1480-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1481-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1482-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1483-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1484-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1485-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1486-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1487-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1488-2019 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.