Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch
Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a surgical instrument that resulted in bone fractures, meeting the criteria for a Severe rating due to significant injury reports.
Plain-English summary
Smith & Nephew, Inc. is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch (Reference 74013988). This reusable surgical instrument is used to prepare the proximal tibia to receive a JOURNEY II XR tibial baseplate. The recall is being conducted because of a higher than anticipated occurrence of bone fracture during the use of the instrument.
The affected units were distributed in the United States to Oregon and Tennessee, as well as internationally to Japan. The specific batch numbers involved in this recall are 17JGA0022, 17JGA0022A, 17JGA0022B, 17JGA0028, 17JGA0028A, 17JGA0028B, 17JGA0034A, 17JGA0034C, 17JGA0044, 17JGA0044B, 17JGA0044R, 18BGA0015A, and 18BGA0015B.
Healthcare facilities and distributors should stop using the affected instruments and contact Smith & Nephew for instructions on return or replacement. The U.S. Food and Drug Administration has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 65
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Batch Numbers: 17JGA0022
- 17JGA0022A
- 17JGA0022B
- 17JGA0028
- 17JGA0028A
- 17JGA0028B
- 17JGA0034A
- 17JGA0034C
- 17JGA0044
- 17JGA0044B
- 17JGA0044R
- 18BGA0015A & 18BGA0015B
Distribution
Part of a larger recall action
This product is one of 4 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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