SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft ti

FDA device recall Z-0140-2013 · posted 2012-10-25 · Terminated

Recall details

Recalling firm

DePuy Mitek, Inc., a Johnson & Johnson Co.

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Action taken

DePuy Mitek sent an Urgent Voluntary Product Recall letter dated September 6, 2012, to all affected customers. Dr Doctor letters were included with the recall letter. Recall is coordinated with Stericycle , contact 1-888-202-3694 The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the enclosed Business Reply Form, even if they have no product remaining in their inventory. Customers were instructed to isolate all inventory of the affected product and return to Stericycle at the following address or fax to 1-888-912-2189 with the completed Business Reply Form: Stericycle 2670 Executive Drive, Suite A Indianapolis, IN 46241 Attn: Event #8874 Customers with questions were instructed to call 1-888-202-3694. For questions regarding this recall call 508-880-8100.

Root cause

Device Design

Status

Terminated

Product code

HWC

Quantity affected

1315 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of AE, AR, AT, AU, BE, BR, CA,, CH,CL .CN, CO, CZ,DE, DK, EC, ES, FI, FR GB, GP, GR, IE, IL, IN, IT, KR, LU, LY, MX, NC NL, NO, NZ, PE, PL P

Date initiated

2012-09-06

Date posted

2012-10-25

Date terminated

2015-06-03

Location

Raynham, MA

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