Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm, a hip prosthesis component. The lot number on the product labeling is the unique identifier of this component.
FDA Recall Z-0799-06 · Posted 2006-04-27
Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeLPH
Date Initiated2006-01-12
Date Terminated2006-07-11
Product QuantityTotal of 30 units
Reason for Recall
Voids in the porous coating of a component used in total hip replacement surgery.
Firm Action
Firm notified all sales agents by letter on January 12, 2006 with instructions to return the product. The second letters went out on January 30, 2006 to the sales associates with instructions to contact the implanting physicians.
Root Cause
Other
Distribution Pattern
Nationwide. Iowa, Florida, California, Arizona, South Dakota, Utah, Missouri, Texas, and Massachusetts, Maryland, Oklahoma, Nevada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.