PRODUCT WARRANTY AND RETURN CONDITIONS

Treace Medical Concepts, Inc. (“TMC”) provides its products subject to the following terms and conditions and by ordering products from TMC, its customers (“Customer”) expressly accept the following terms and conditions: 

1. Limited Warranty; Limitation of Liability. Except as otherwise stated in the written product warranty or warranty disclaimer that (a) is available in electronic format online with respect to certain products, or (b) accompanies the product when delivered to Customer, TMC warrants products to the original purchaser against defects in workmanship and materials for 180 days from the date of purchase from TMC (the “warranty period”), provided that the limitations set forth in this Section 1 will also apply. In addition to the foregoing, capital equipment (including the TMC Percuplasty^® Power System) has a warranty period of 1 year from the date of purchase, and allograft or other tissue products distributed by TMC (“Tissue Products”) are subject to the warranties stated in their applicable labeling and as set forth below. Warranty claims must be received in writing by TMC within the warranty period or, if not so received, are forever waived. TMC may require that Customer return the alleged defective product, freight prepaid, pursuant to TMC’s written authorization before remedying a warranty claim.

TMC’s only liability and the exclusive remedy of Customer in the event of any defect is for TMC to provide at TMC’s option, either (1) a full refund or credit in the amount of the purchase price, or (2) the repair or replacement of the product.

This warranty does not cover: (1) damage caused by misuse (including violation of TMC’s instructions), neglect (including failure to store in accordance with TMC’s instructions and specifications), accident, or causes external to the product; (2) any product on which the serial number or lot code has been removed or made illegible; (3) any product or part thereof that has been modified by anyone other than TMC, unless authorized by TMC or in accordance with the product’s instructions for use; (4) re-use of a product sold for single use; or (5) the removal or defacing of any labeling of the product. 

With respect to Tissue Products, TMC warrants to Customer only that the Tissue Products supplied to Customer have been recovered, processed, manufactured and distributed in substantial compliance with federal and state requirements, including Section 361 of the Public Health Service Act and 21 C.F.R. Parts 1271, as applicable, and in conformance with current industry practice. Customer acknowledges that the Tissue Products are derived from human tissue and that TMC cannot warrant them as free of disease or infectious agents. Customer acknowledges that there are inherent disease risks in the use of human tissue for implantation, transplantation or other transfer into a human recipient, including the risk of latent or emerging infectious agents for which no validated test is yet approved or recognized, and the risk of false negative infectious disease test results. Customer acknowledges that these types of inherent risks cannot be eliminated despite the application of stringent and substantially compliant recovery, manufacturing, and distribution controls by the manufacturer, as required by applicable federal and state law and in conformance with current industry practice. Customer acknowledges that inherent disease risks exist with all Tissue Products supplied by TMC and agrees that TMC will not be liable for any injuries, damages, or death resulting in whole or in part from the implantation, transplantation, or other transfer of the Tissue Products into human recipients. Customer further acknowledges that natural variability exists in the consistency and quality of the source material despite the strength, durability, or similar characteristics of any Tissue Product, and TMC makes no warranty as to the suitability of any Tissue Product for medical or surgical use.

TMC WARRANTIES ARE LIMITED EXCLUSIVELY TO THIS EXPRESS WARRANTY. ANY OTHER WARRANTIES OF ANY KIND OR DESCRIPTION WHATSOEVER, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, EXPRESSED OR IMPLIED, ARE HEREBY DISCLAIMED.

TMC will not be liable for any indirect, consequential, incidental, punitive, special, exemplary, or contingent loss or damage (including without limitation lost or anticipated profits and savings or damage to goodwill) arising from or in connection with the purchase, use of, or inability to use, or unavailability of, the TMC products or otherwise in connection with this Agreement, even if TMC has been advised of the likelihood of such damages. TMC’s maximum aggregate liability for any loss, damage, injury or expense related to its products, services or this Agreement, whether such liability arises out of breach of contract, negligence or otherwise, will not exceed the actual amounts paid by Customer to TMC for the TMC product(s) involved in such claim. The limitations in this section will not preclude any liability which, under applicable products liability law, cannot legally be precluded by contract.

2. Return of Goods.  Prior to returning any product, Customer must request authorization from TMC by completing and submitting a Return Goods Authorization Form (RGA Form) from TMC Customer Service.  A prepaid shipping label will be provided to Customer upon issuance of a return of goods authorization by TMC.

a. Products returned within 30 days of the date of invoice will be credited at the Customer’s invoice price.

b. Products returned after 30 days but not longer than 90 days from the date of invoice will be credited at the Customer’s invoice price less a 15% restocking charge.

c. Product return requests initiated beyond 90 days of the date of invoice are not authorized.

d. The following items are not eligible for return (regardless of timing): capital equipment; obsolete products; damaged, custom made or altered products; sterile products which have open cartons; mixed sterile lot numbers; expired products; or TMC products that were not purchased directly from TMC or TMC’s authorized distributors/agents.

All authorized returns are also subject to the following terms: 

a. Products shipped in error by TMC will receive full invoice credit if returned within 30 days of receipt by Customer in their unopened, original factory package.

b. Invoice copy or invoice number, part number, lot number and date of purchase must be provided to TMC Customer Service with the RGA Form.

c. Products that have been opened or are not in their original packaging are disallowed for full credit; the amount credited will be determined by a quality assurance inspection, in TMC’s sole discretion.