—#142186

Product

SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.

FDA product code: HTO — Reamer
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Part number: 352.135; Lot number: F-17180

Why it was recalled

The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.

Root cause (FDA determination)

Process design

Action the firm took

On Dec 1, 2015, Synthes issued a recall notification letter and requested that all consignees review inventory and contact Synthes for a return authorization number. The verification form is to be completed and sent to Stericycle.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: US nationwide distibution.

Timeline

Recall initiated: 2015-12-01
Posted by FDA: 2016-01-05
Terminated: 2016-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142186. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.