Z-0144-2013Class II

SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to...

Name: Z-0144-2013 SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to...
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2012-09-06
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2012-09-06 / Terminated / root cause: design

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair... on 2012-09-06. FDA classified it as Class II and gives the reason as "Fracture of SPIRALOK Anchors post op, requiring patient revision". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0144-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-06
Posted: 2012-10-25
Terminated: 2015-06-03
Recalling firm: DePuy Mitek, Inc.
Product: SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Product code: HWC Screw, Fixation, Bone
Reason for recall: Fracture of SPIRALOK Anchors post op, requiring patient revision
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 400 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 PT, RE, RU, SG, SI, TH, TN, TR, UG ,UY , VE, and ZA.
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0144-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0140-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0141-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0142-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0143-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0144-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0145-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0146-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0147-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0148-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0149-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0150-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0151-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0152-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0153-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0154-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0155-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25

Product code HWC

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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)