Z-2228-2013Class II

OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290...

Name: Z-2228-2013 OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290...
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2013-08-06
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2013-08-06 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor on 2013-08-06. FDA classified it as Class II and gives the reason as "Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2228-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-06
Posted: 2013-09-17
Terminated: 2016-04-20
Recalling firm: Smith & Nephew, Inc.
Product: OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor
Product code: JDR Staple, Fixation, Bone
Reason for recall: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Root cause tag: packaging
FDA root cause: Packaging
Action: Smith&Nephew sent an Urgent Product Recall Notification letter dated August 6, 2013, via Federal Express to all affected customers. Addendum customer letters for 4 additional part numbers were sent via Federal Express on August 19, 2013, The letters identified the product, the problem, and the action to be taken by the customer. Customers were asked to inspect their inventory, locate unused devices and quarantine them. Customers were also asked to complete the last three columns in the inventory Return Certification form indicating the quantities that need to be returned, and include their contact information in the spaces provided. Customers were instructed to contact Smith & Nephew's Demo Service Departmentat 800-343-5717 for a Return Authorization (RA#), and provide the information response form. Replacement product would be provided. For questions regarding this recall call 978-749-1073.
Quantity in commerce: 10296 US
Distribution: Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
Product codes and lots: 50364854 50366872 50366972 50366980 50366985 50366989 50370760 50370771 50370940 50371292 50376475 50385813 50386237 50386563 50386749 50388066 50391012 50394695 50396184 50400301 50400306 50400307 50403488 50404241 50406445 50407524 50407571 50410789 50411371 50414977 50415258 50415670 50416148 50417206 50418093 50418993 50420658 50423443 50429652 50430190 50430402 50431731 50433933 50435319 50441441 50442649 50444415 50445034 50445760 50447482 50448060 50448722 50450469 50451783 50453148 50454104 50455627 50456912 50458608 50460242

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2228-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2215-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2216-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2217-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2218-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2219-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2220-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2221-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2222-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2223-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2224-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2225-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2226-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2227-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2228-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2229-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2230-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2231-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2232-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2233-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2234-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2235-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2236-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2237-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2238-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2239-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2240-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17

Product code JDR

K082215Class IIOsteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division / cleared 2008-11-03

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)