—#140745

Product

Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device.

FDA product code: EZX — Mesh, Surgical, Metal
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Threaded Plate Holder-Long for 3.5mm Locking Hole Part Numbers Lot Numbers 324.031 8225613

Why it was recalled

The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 10/5/2015 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s). " Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. " Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Even if you do not have any product. " Send a copy of the completed Verification Section by: Fax: 844-721-3048 or Scan/email: Synthes4704@stericycle.com. " Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 3 of the notification. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: US (nationwide) and country of: Canada.

Timeline

Recall initiated: 2015-10-07
Terminated: 2016-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140745. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.