Recall Z-2228-2013
Smith & Nephew, Inc. Endoscopy Division · initiated August 6, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor
Codes / 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
Reason for recall
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
FDA-determined cause: Packaging
Action taken
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.
Details
- Recall number
- Z-2228-2013
- Initiated
- August 6, 2013
- Posted by FDA
- September 17, 2013
- Terminated
- April 20, 2016
- Product code
- JDR – Staple, Fixation, Bone
- Quantity
- 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…
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division, Andover, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2215-2013 Class II | BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2216-2013 Class II | BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2217-2013 Class II | BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2218-2013 Class II | BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2219-2013 Class II | BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2220-2013 Class II | OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2221-2013 Class II | OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2222-2013 Class II | OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2223-2013 Class II | OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2224-2013 Class II | OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2225-2013 Class II | OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2226-2013 Class II | OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2227-2013 Class II | OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2229-2013 Class II | TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2230-2013 Class II | TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2231-2013 Class II | TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2232-2013 Class II | TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2233-2013 Class II | TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2234-2013 Class II | TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2235-2013 Class II | TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2236-2013 Class II | TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2237-2013 Class II | RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2238-2013 Class II | TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2239-2013 Class II | TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2240-2013 Class II | TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |