—#196197

Product

SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.

FDA product code: JDR — Staple, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K142292
Affected lot / code info: UDI-DI (GTIN): 00810633020494 Lot MSE210237 Expiry 11/1/2026

Why it was recalled

The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.

Root cause (FDA determination)

Error in labeling

Action the firm took

On September 27, 2022, the firm notified affected customers via urgent medical Device Recall letters. Customers were instructed to examine their inventory to determine if they have affected product and to quarantine them immediately - Customers should not use the recalled products. Customers should contact their DePuy Synthes Sales Consultant or call the customer support services at ra-dpyus-csspecial@its.jnj.com to coordinate the return/credits of the subject products.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2022-09-27
Posted by FDA: 2022-10-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196197. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.