Recall Z-2221-2013— Smith & Nephew, Inc. Endoscopy Division
Class II · Terminated
Class II FDA medical device recall by Smith & Nephew, Inc. Endoscopy Division, initiated 2013-08-06, terminated 2016-04-20. It names one FDA 510(k) clearance: K082215. Product: OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor. Reason: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier..
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-06
- Terminated
- 2016-04-20
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor
Reason for recall
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Data sourced from openFDA. This site is unofficial and independent of the FDA.