Medical Device Advisories

FDA Advisory No. 2017-237 || VOLUNTARY PRODCUCT RECALL OF PHYSIOMESH COMPOSITE MESH (MDR-00270)

FDA Advisory No. 2017-237

VOLUNTARY PRODCUCT RECALL OF PHYSIOMESH COMPOSITE MESH (MDR-00270)

The Food and Drug Administration informs the public that Johnson and Johnson (Phils.) Inc., the Marketing Authorization Holder (MAH), has voluntarily recalled, removed and destroyed ETHICON Physiomesh Flexible Composite Mesh – MDR-00270 (for laparoscopic use) from the Philippine market.

The MAH conducted these activities at the request of the Ethicon Medical Safety Team after a review of unpublished data from two (2) large independent hernia registries (Herniamed German Registry and Danish Hernia Database-DHDB). Based on the data, there are higher revision rates between Physiomesh flexible composite and other meshes in the registries after laparoscopic ventral hernia repair due to a multifactorial issue. Consequently, this discrepancy of Ethicon Physiomesh Composite Mesh product line has not been fully characterized. Thus, a worldwide device removal has been conducted and it is communicated to the U.S. Food and Drug Administration (US FDA).

In coordination with the FDA Philippines, the recall, removal and destruction of the medical device has been completed. The summary of the affected batch of products recalled and destroyed are as follows:   

Product Code

Batch Number

PHY1015V

HK8DGKB0

JD8DCTB0

JD8DKLB0

JD8GDBB0

JK8CCLC0

JK8DSMC0

JL8GRWD0

JM8GPZD0

KB8BBJD0

PHY1515Q

EE8KHZA0

 

HL8DZHB0

 

HL8HKLB0

 

HP8BJZB0

 

JD8GDCB0

 

JE8BCXB0

 

JJ8DTXC0

 

JK8BKTC0

 

JK8CKZC0

 

JM8CQDD0

 

KA8HDQD0

PHY1520R

HL8DTWB0

 

JD8CRJB0

 

JD8DXHB0

 

JE8BRXB0

 

JM8CZZD0

PHY1520V

EB8HCTAO

 

HP8DBKB0

 

JK8HCC0

PHY2025V

JB8BBXB0

 

JB8DDGB0

 

JB8DRGB0

 

JK8BSXC0

 

JL8BMHD0

 

JP8BMZD0

 

KA8GGKD0

PHY2030R

HM8DQWB0

 

HM8GCLB0

 

HP8CJBBO

Dissemination of the above information to all concerned is requested.

Share Us on

Submit to FacebookSubmit to Google PlusSubmit to Twitter