Z-0058-2012

ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 2.0 SUTURE, REF 5100-002, 1 each, STERILE R...

Name: Z-0058-2012 ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 2.0 SUTURE, REF 5100-002, 1 each, STERILE R...
Creator: Wright Medical Technology Inc
Published: 2011-09-20
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2011-09-20 / Terminated / root cause: labeling and UDI

FDA source

Wright Medical Technology Inc began a recall of ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 2.0 SUTURE, REF 5100-002, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline... on 2011-09-20. The reason FDA records is "The product is labeled with an expiration date without adequate justification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0058-2012
Status: Terminated
Initiated: 2011-09-20
Posted: 2011-10-18
Terminated: 2012-07-17
Recalling firm: Wright Medical Technology Inc
Product: ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 2.0 SUTURE, REF 5100-002, 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
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: The product is labeled with an expiration date without adequate justification.
Root cause tag: labeling and UDI
FDA 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: [email protected]. For questions regarding this recall contact 901-867-4324.
Quantity in commerce: 1099 units
Distribution: Worldwide Distribution - USA (nationwide) and countries of: Argentina, Canada, Denmark, France, Great Britain, Ireland, Japan, and Spain.
Product codes and lots: Lot Numbers: 01816080116, 02916090218, 03716070304, 03816080307, 03916090316, 04016100426, 04116110421, 05016100513, 05916090502, 06516050616, 06616060627, 06916090617, 07716070725, 07816080721, 09016100923, 09816080905, 09916090905, 10916091012, 11516051115, 11516051122, 11616061107, 12516051207, 12916091221

Product code MBI

K971282Class IIAnchorlok and Anchorlok Rl Soft Tissue Anchor SystemWrightmedicaltechnologyinc / cleared 1997-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)