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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:143613

Product 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD 2 801802230 12/14 COCR FEMORAL HEAD 2 801802601 12/14 COCR FEMORAL HEAD 2 801802602 12/14 COCR FEMORAL HEAD 2 801802603 12/14 COCR FEMORAL HEAD 2 801802604 12/14 COCR FEMORAL HEAD 2 801802605 12/14 COCR FEMORAL HEAD 2 801802801 12/14 COCR FEMORAL HEAD 2 801802802 12/14 COCR FEMORAL HEAD 2 801802803 12/14 COCR FEMORAL HEAD 2 801802805 12/14 COCR FEMORAL HEAD 2 801802814 12/14 COCR FEMORAL HEAD 2 801803201 12/14 COCR FEMORAL HEAD 3 801803202 12/14 COCR FEMORAL HEAD 3 801803203 12/14 COCR FEMORAL HEAD 3 801803205 12/14 COCR FEMORAL HEAD 3 801803214 12/14 COCR FEMORAL HEAD 3 801803601 12/14 COCR FEMORAL HEAD 3 801803602 12/14 COCR FEMORAL HEAD 3 801803603 12/14 COCR FEMORAL HEAD 3 801803604 12/14 COCR FEMORAL HEAD 3 801803605 12/14 COCR FEMORAL HEAD 3 801804001 12/14 COCR FEMORAL HEAD 4 801804002 12/14 COCR FEMORAL HEAD 4 801804003 12/14 COCR FEMORAL HEAD 4 801804004 12/14 COCR FEMORAL HEAD 4 902602100 6 DEGREE COCR FEM HEAD 22 32902603935 FEM HD 26MMDIA SHT NK+ 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORAL HEAD +3.5 X 22 MM 32902604845 FEMORAL HEAD +7.0 X 22 MM For use in total or hemi hip arthroplasty

Official recall number

Z-1100-2016

Evidence summary

Product code
LPH
Recall status
Terminated
Event initiated
January 11, 2016
Root cause
Packaging
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1100-2016

Field note

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