FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
- Recall number
- Z-0099-2023
- Recalling firm
- Synthes (USA) Products LLC
- Product
- SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
- Status
- Open, Classified
- Initiated
- 2022-09-27
- Posted
- 2022-10-18
- Terminated
- not on file
- Reason
- 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
- 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 ra-dpyus-csspecial@its.jnj.com to coordinate the return/credits of the subject products.
- Quantity
- 94 US; 30 OUS
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026
- 510(k) numbers
- ["K142292"]
- PMA numbers
- not on file
- Product code
- JDR
- Firm FEI
- 3008812560
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28