Z-0098-2023Class II

SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT...

Name: Z-0098-2023 SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT...
Creator: Synthes (USA) Products LLC
Published: 2022-09-27
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2022-09-27 / Open, Classified / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone... on 2022-09-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0098-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-27
Posted: 2022-10-18
Recalling firm: Synthes (USA) Products LLC
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.
Product code: JDR Staple, Fixation, Bone
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
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.
Quantity in commerce: 81
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI (GTIN): 00810633020494 Lot MSE210237 Expiry 11/1/2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0098-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0098-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-18
Z-0099-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-18
Z-0100-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-18
Z-0101-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-18

Product code JDR

K142292Class IISpeed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. / cleared 2014-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)