Recall Z-2234-2013— 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. FDA's recall record names no specific 510(k) clearance for this event. Product: TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 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
Product description
TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 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.