Recall Z-1461-2019
Zimmer GmbH · initiated April 8, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CBS high, countersink, cannulated, AO, Item Number 503004542
Codes / lots: All items marked with "Normed" are affected
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: Under Investigation by firm
Action taken
Urgent Medical Device Recall notification letters dated 4/8/19 were sent to customers.
Details
- Recall number
- Z-1461-2019
- Initiated
- April 8, 2019
- Terminated
- May 11, 2020
- Product code
- HWW – Countersink
- 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.
- Recalling firm
- Zimmer GmbH, Winterthur
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1413-2019 Class II | Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1414-2019 Class II | Drill Sys2.7, 2x103mm, AO, Item Number 502015107An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1415-2019 Class II | Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1416-2019 Class II | Drill, 15mm stop, 1x76mm, AO , Item Number 502015115An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1417-2019 Class II | Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1418-2019 Class II | Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015124An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1419-2019 Class II | Drill, 26mm stop, 1.9x94mm, Stryker, Item Number 502015130An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1420-2019 Class II | Drill, 19mm stop, 1.9x87mm, AO, Item Number 502015131An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1421-2019 Class II | Drill, 2.5x94mm, Stryker, Item Number 502015136An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1422-2019 Class II | Drill, 2.5x87mm, AO, Item Number 502015137An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1423-2019 Class II | Drill, 2.5x135mm, AO, Item Number 502015142An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1424-2019 Class II | Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1425-2019 Class II | Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015146An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1426-2019 Class II | Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number 502015206An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1427-2019 Class II | Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number 502015207An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1428-2019 Class II | Drill for 2.7mm screw, 2x100mm, AO, Item Number 502015208An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1429-2019 Class II | Drill for 2.7mm screw, 2x125mm, Stryker, Item Number 502015211An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1430-2019 Class II | Drill for 2.7mm screw, 2x120mm, AO, Item Number 502015212An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1431-2019 Class II | Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502015213An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1432-2019 Class II | Drill for 3.5mm screw, 2.5x120mm, AO, Item Number 502015216An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1433-2019 Class II | Drill, 2.7x125mm, AO, Item Number 502015217An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1434-2019 Class II | Drill for 3.5mm screw, 2.5x125mm, stryker, Item Number 502015218An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1435-2019 Class II | Drill, cannulated, 4x120mm, AO, Item Number 502015402An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1436-2019 Class II | Drill, cannulated, 4x150mm, AO, Item Number 502015403An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1437-2019 Class II | Drill, cannulated, 2x95mm, round shaft, Item Number 502015619An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1438-2019 Class II | Drill, cannulated, 2.5x95mm, round shaft, Item Number 502015620An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1439-2019 Class II | Drill, cannulated, 2.5x95mm, AO, Item Number 502015621An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1440-2019 Class II | Drill, cannulated, 2x95mm, AO, Item Number 502015623An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1441-2019 Class II | Drill, cannulated, 2.8x120mm, AO, Item Number 502015628An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1442-2019 Class II | Drill, cannulated, 2.8x150mm, AO, Item Number 502015629An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |