Biomet Surgical Implant Reamer Recall: Packaging Sterile Barrier Risk
Biomet is recalling surgical implant reamers due to packaging that may lose sterile barrier integrity, risking post-surgical infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of surgical implants with compromised sterile barrier integrity that poses risk of post-surgical infection. The rubric specifies Level 3 for 'risk-of-harm products where injury has not yet been reported'; no illnesses or injuries are documented in the source.
Plain-English summary
Biomet, Inc. is recalling JUGGERLOC SLOTTED REAMER surgical implants in sizes 5MM through 8MM distributed worldwide to 28 U.S. states, Australia, Japan, and the Netherlands. The recall affects 702 units across 29 affected lots.
The vacuum-sealed packaging may not have sufficient adhesion on all sides, potentially compromising the device's sterile barrier. A compromised sterile barrier increases the risk of post-surgical infection at the implant site.
Infection resulting from a compromised barrier may require additional surgical intervention or extension of the original surgery. Patients who received one of these devices should contact their healthcare provider to determine if their specific device is affected.
Healthcare facilities should immediately identify affected lot numbers in their inventory and discontinue use of the recalled devices. This is a Class II recall from the FDA.
The recalled product
- Product
- BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels.…
- Manufacturer
- Biomet, Inc.
- Affected units
- 702
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 (20)
- 29 lots: Lot Number
- UDI Number - [061400
- (01)00887868465758(17)310630(10)061400]
- [061410
- (01)00887868465758(17)310723(10)061410]
- [089370
- (01)00887868465758(17)310726(10)089370]
- [260770
- (01)00880304857261(17)310917(10)260770]
- [503410
- (01)00880304857285(17)311011(10)503410]
- [503420
- (01)00880304857261(17)310924(10)503420]
- [503430
- (01)00880304857285(17)311011(10)503430]
- [503450
- (01)00880304857261(17)310924(10)503450]
- [503460
- (01)00880304857285(17)311011(10)503460]
- [503610
Distribution
Part of a larger recall action
This product is one of 4 recalled by Biomet, 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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