Recalls / —

—#48343

Product

Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486

FDA product code

LXH — Orthopedic Manual Surgical Instrument

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

Catalog Number 71440480 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes.  Catalog Numbers 71440482 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes.  Catalog Number 71440484 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes.  Catalog Number 71440486 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes.

Why it was recalled

Tibial punches were not manufactured to specification and could break at the tip during use.

Root cause (FDA determination)

Other

Action the firm took

Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email and telephone follow-up) on 08/29/2006 to request the return of any in stock product.

Recalling firm

Firm

Smith & Nephew Inc

Address

1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern

Worldwide distribution ----- including USA and countries of Austria, Australia, Belgium, Canada, China, Dubai, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, South Korea, Spain, Turkey, United Kingdom, and Venezuela.

Timeline

Recall initiated

2006-08-29

Posted by FDA

2006-10-03

Terminated

2010-04-12

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #48343. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.