FDA Medical Device Recalls (openFDA)
Wright Medical Technology Inc: ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 3.5mm, 2 SUTURE, REF 5100-0014, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Product Usage: The instrument is used as a soft tissue anchor
- Recall number
- Z-0064-2012
- Recalling firm
- Wright Medical Technology Inc
- Product
- ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 3.5mm, 2 SUTURE, REF 5100-0014, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Product Usage: The instrument is used as a soft tissue anchor
- Status
- Terminated
- Initiated
- 2011-09-20
- Posted
- 2011-10-18
- Terminated
- 2012-07-17
- Reason
- The product is labeled with an expiration date without adequate justification.
- Root cause
- Incorrect or no expiration date
- Action
- The firm, Wright Medical Technology, Inc., sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated September 20, 2011 to all affected consignees. The letters identified the products, the problem, and the actions to be taken. The letter instructed consignees to identify affected inventory. If recalled products are located consignees are instructed to contact customer service at 1-800-238-7117, for specific instructions on how to return the recalled products. The letter asked that this communication be forward to any associated sites if the recalled products were further distributed. Consignees are to complete and return the enclosed notification form by fax to 901-867-7401 or by email to: cathy.park@wmt.com. For questions regarding this recall contact 901-867-4324.
- Quantity
- 4472 units
- Distribution
- Worldwide Distribution - USA (nationwide) and countries of: Argentina, Canada, Denmark, France, Great Britain, Ireland, Japan, and Spain.
- Lot, serial or model codes
- Lot Numbers: 01516050108, 02916090204, 02916090209, 03016100308, 03716070319, 03916090306, 03916090313, 04116110428, 04416040428, 04516050419, 04916090403, 05116110513, 05516050505, 05516050517, 06016100604, 06416040622, 06616060607, 06616060630, 06716070601, 06716070622, 06916090626, 07416040723, 07616060721, 07816080702, 07816080702, 07816080710, 08016100728, 08016100820, 08416040828, 08616060801, 08716070808, 08816080805, 08916080906, 09916090902, 10716071002, 10816081030, 10916091013, 11316031114, 11616061112, 11716071104, 12316031210, 12816081204, 12916091228
- 510(k) numbers
- ["K971282"]
- PMA numbers
- not on file
- Product code
- MBI
- Firm FEI
- 1043534
- Firm city
- Arlington
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28