—#94611

Product

3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly for patients with osteopenic bone

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K082625
Affected lot / code info: Catalog/model numbers: 02.123.020, 02.123.020S, 02.123..021, 02.123.021S, 02.123.022, 02.123.022S, 02.123.023, 02.123.023S, 02.123.024, 02.123.024S, 02.123.025, 02.123.025S, 02.123.026, 02.123.026S, 02.123.027, 02.123.027S, 02.123.028, 02.123.028S, 02.123.029, 02.123.029S, 02.123.030, 02.123.030S, 02.123.031, 02.123.031S, 02.123.032, 02.123.032S, 02.123.033, 02.123.033S, 02.123.040, 02.123.040S, 02.123.041, 02.123.041S, 02.123.042, 02.123.042S, 02.123.043, and 02.123.043S. Lot numbers range form 6371761 through 6443098.

Why it was recalled

screw can pass through plate hole

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Synthes (USA) notified all Synthes Trauma Hospital accounts of record of this recall via an Urgent Medical Device Recall letter dated September 27, 2010. The notification included instructions for hospital accounts to immediately cease use of the product, examine inventory, remove the 3.5 mm LCP Periarticular Proximal Humerus Plates from their shelves and complete and return the attached Verification Section form via mail: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132; fax: 610-215-9005 or Scan/email: FieldAction@synthes.com. If they have any of the identified devices, they were to call Synthes at 1-800-479-6329 to obtain Authorization number prior to completing Verification form. If you have any questions, please call 1-800-620-7025 x5403 or contact your Synthes Trauma Sales Consultant.

Recalling firm

Firm: Synthes USA (HQ), Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Worldwide distribution: USA and countries including: Bermuda, Korea, Italy, Japan, Georgia, Qatar and Turkey

Timeline

Recall initiated: 2010-09-16
Posted by FDA: 2010-11-02
Terminated: 2015-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94611. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.