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Open, Classified

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 Recall Z-0098-2023 · Posted 2022-10-18

Recalling FirmSynthes (USA) Products LLC
Recall StatusOpen, Classified
Product CodeJDR
Date Initiated2022-09-27
Product Quantity81

Reason for Recall

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.

Firm Action

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 [email protected] to coordinate the return/credits of the subject products.

Root Cause

Error in labeling

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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