—#141513

Product

2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K012114, K040588, K050110, K063049, K102694, K103243
Affected lot / code info: Part Number Lot Number Product Description 212.818 7856527 Synthes 2.4mm Locking Screw SLF-TPNG with Stardrive Recess 18mm

Why it was recalled

It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System).

Root cause (FDA determination)

Process control

Action the firm took

Synthes sent an "URGENT FIELD SAFETY NOTIFICATION" letter dated November 2, 2015. Customers were asked to take the following actions: -Review the correct package insert (GP2615, attached). -If found, discard incorrect package insert associated with the locking screw noted in the table above. -Forward this Field Safety Notification to anyone in your facility that needs to be informed. -If the package insert has been forwarded to another facility, contact that facility. -Complete the attached Verification Section (page 3 of this notification). Please include your name, title, address, telephone number and signature in the spaces provided. ---Send a copy of the completed Verification Section by: -Fax: 877-907-7514 or Scan/email: Synthes7766@stericycle.com -If the Verification Form 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 in page three (3) of this notification. -Maintain a copy of this Notification.

Recalling firm

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

Distribution

Distribution pattern: Distributed in the states of IA, OH, CO, FL, TX, MA, NY, OR, SC, VA, WV, TN, MO, PA, CT, GA, WA, CA, AL, , IN, MI, NJ, VT, ID, KS, MN, and MD, and the country of Canada.

Timeline

Recall initiated: 2015-11-02
Terminated: 2016-07-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141513. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.