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.
This recall has been terminated (originally issued August 15, 2018).
- Company
- Trimed Inc.
- Recall Initiated
- August 15, 2018
- Recall Number
- Z-0366-2020
- Quantity
- 583 Bone Plates
- Firm Location
- Santa Clarita, CA
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of MD, UT.
Lot / Code Info
Lot # 110631.
Root 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)