Synthes (USA)
Country not established
- Devices
- 417
- FDA recalls
- 5
What Synthes (USA) makes
The company manufactures orthopedic fixation devices, including locking compression plates for the distal femur and proximal humerus, clavicle hook plates, trochanteric fixation nails, and external fixators. Their portfolio also covers reconstruction plates for the mandible and radius, dynamic compression locking systems, and self-drilling screws for bone stabilization. Additional products include bone cement (NORIAN SRS Fast Set Putty) and modular orthopedic hardware for fracture and trauma management.
These devices are classified under FDA categories Class I, Class II, and Unclassified (U), with most submissions supported via 510(k) clearance. The company’s products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Search and filter all 417 devicesShowing 401-417 of 417
FDA recalls
FDA recall records list 5 recalls initiated by Synthes (Usa), the earliest on 2006-03-30 and the most recent on 2017-08-10. By recorded status: 5 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 2
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 10 Aug 2017 Z-0617-2018 Class II Terminated The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.
- 10 Aug 2017 Z-0618-2018 Class II Terminated The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.
2011
- 29 Sep 2011 Z-0460-2012 Unclassified (pre-2012) Terminated A recent shipment carrying Norian SRS was lost by the carrier. Since the product was lost before final product release testing, Synthes is unable to confirm that Part Number SRS-005-FSP- Lot Number N001101 meets final product release requirements. The product contains all final labeling and cannot be visually distinguished from the product that has met final product release requirements.
Full distribution text
- 29 Sep 2011 Z-0460-2012 Unclassified (pre-2012) Terminated A recent shipment carrying Norian SRS was lost by the carrier. Since the product was lost before final product release testing, Synthes is unable to confirm that Part Number SRS-005-FSP- Lot Number N001101 meets final product release requirements. The product contains all final labeling and cannot be visually distinguished from the product that has met final product release requirements.
2008
- 23 Jul 2008 Z-2395-2008 Unclassified (pre-2012) Terminated The product is mislabeled, as the validation for the previous sterilization parameters cannot be replicated. The currently validated sterilization parameter is a minium of 24 minutes prevacuum.
2006
- 30 Mar 2006 Z-0792-06 Unclassified (pre-2012) Terminated Integrity of outer mylar pouch could be compromised, possibly rendering the exterior of the inner foil pouch unsterile.
Full distribution text
- 30 Mar 2006 Z-0792-06 Unclassified (pre-2012) Terminated Integrity of outer mylar pouch could be compromised, possibly rendering the exterior of the inner foil pouch unsterile.