Recall Z-0366-2020
TriMed Inc. · initiated August 15, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additional stabilization.
Codes / lots: Lot # 110631.
Reason for recall
The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.
FDA-determined cause: Employee error
Action taken
On 08/15/2019 and 9/13/19, the firm issued a recall notice to affected consignees via email. The recall notification informed consignees of the following: 1. Review your inventory to see if you have any of the impacted product. If you have impacted product within your inventory, remove the product use. Do not implant the impacted product. Contact TriMed at quality@trimedortho.com or call 800-633-7221. TriMed will arrange to have the impacted product returned to the company. 2. Review your records to see if the impacted product was implanted. If you have records that impacted product was implanted, medical judgment should be applied to determine whether additional patient monitoring activities should be performed to evaluate implant placement, implant structural integrity, and fracture union. 3. Return the Recall Response card attached to this letter to TriMed as soon as possible. 4. Please contact TriMed via telephone or email as per below if you have any questions:, Telephone*: 800-633-7221 Email: quality@trimedortho.com, Hours of operation: 8:00AM to 5:00PM PST (Monday through Friday, excluding holidays)
Details
- Recall number
- Z-0366-2020
- Initiated
- August 15, 2018
- Product code
- HRS – Plate, Fixation, Bone
- Quantity
- 583 Bone Plates
- Distribution
- US Nationwide distribution in the states of MD, UT.
- Recalling firm
- TriMed Inc., Santa Clarita, CA